Clinical Trials for Insomnia

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Insomnia from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 10
• Active, not recruiting: 4
• Completed: 18
• Other: 18

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT04629547 — Sleep Trial to Prevent Alzheimer’s Disease

The purpose of this study is to determine if treatment with the sleep aid suvorexant can decrease the rate of amyloid-β (Aβ) accumulation in the brain.

NCT06109363 — A Stepped Care Model to Deliver CBT-I in Community

Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due t…

NCT05924425 — Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease

DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.

NCT06559306 — Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective …

NCT07045792 — Body Awareness Therapy in High Stressed Young Adults: Effects on Function, Balance, Sleep and Mood

Body Awareness Therapy (BAT) is a holistic approach to human movement that considers the physical, physiological, psychological, and existential aspects of human existence. This planned randomized controlled study will be conducted on young adults with high stress levels. One group will be subjected to BAT and the other group will be the control group. The BAT exercises will be performed in sup…

NCT06671600 — Effects of Osteopathic Manipulative Treatment Protocol on Sleep Quality in Parkinson’s Disease Subjects

Parkinsonism, mainly caused by Parkinsons disease (PD), includes symptoms like tremors, stiffness, slow movements, and balance problems. These symptoms can make it hard for people to sleep well, which leads to a lower quality of life and can increase the risk of other health issues and cognitive decline.

Osteopathic manipulative treatment (OMT) is a hands-on approach that may help improve slee…

NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain

The purpose of this research study is to test whether Brief Behavioral Treatment for Insomnia (BBTI) delivered over the phone or Brief Mindfulness Training (BMT) delivered over the phone is better able to improve the symptoms of insomnia, reduce chronic pain, and slow the pace of biological aging in individuals with HIV and Chronic Pain.

NCT07554235 — Auricular Acupuncture Therapy Administered by Village Doctors Improves Sleep Quality in Elderly Patients With Comorbid Diabetes Mellitus and Hypertension

This study aims to apply traditional auricular press-needle acupuncture to treat sleep disturbances in elderly patients (aged ≥65 years) with comorbid diabetes mellitus and hypertension in rural areas of China. Given the complex bidirectional relationship between diabetes mellitus with hypertension and sleep disturbances, this cluster randomized trial is designed to test whether a village docto…

NCT07529626 — Association Between Chronic Psychological Stress and Disease Course Outcomes in Pancreatic Cancer

This is a prospective, observational cohort study (MIND-PANC) to explore the associations of chronic psychological stress with disease progression, treatment outcomes, and prognosis of pancreatic cancer.

Researchers will ask participants to fill out simple questionnaires about their mood, worries, and sleep at the start of the study and at regular follow-up visits. The study will also collect …

NCT07552714 — Thread Embedding Plus Auricular Acupressure for Non-Organic Insomnia Based on Traditional Medicine Pattern Differentiation

Non-organic insomnia is a prevalent disorder that significantly impairs quality of life, characterized by difficulty initiating or maintaining sleep alongside daytime functional decline. This condition is particularly common among adults facing chronic stress, which increases the risk of chronic diseases and dysregulates the Microbiota-Gut-Brain Axis (MGBA)-a bidirectional communication system …

Active, Not Recruiting

NCT05840822 — Evaluating Efficacy and Safety of CBD TPM Capsules for Use in Insomnia

Insomnia is a common sleep disorder in which a person has difficulty falling asleep or staying asleep or getting good quality sleep. Consequences of insomnia include daytime sleepiness, poor memory function, decline in concentration with negative impacts on social and work activities. Although medical cannabis and cannabis products are widely used worldwide for the management of symptoms associ…

NCT06640023 — The Study in Outpatient Medicine Using Nudges to Improve Sleep

The goal of this clinical trial is to learn if electronic health record (EHR) nudges (changes to the EHR that do not restrict freedom of choice or alter incentives) can reduce Z-drug prescribing in primary care clinics for patients with insomnia. The main questions it aims to answer are:

1. Can Z-drug prescribing be reduced by setting the dispense quantity default of new Z-drug orders in the E…

NCT07674316 — Effect of Menopausal Hormone Therapy on Sleep

The Effect of Menopausal Hormone Therapy on Sleep (menoSLEEP) study is investigating the effects of menopausal hormone therapy (MHT) on sleep problems in peri- and postmenopausal women with an indication for MHT. The aim of the study is to find out whether MHT improves subjective and objective sleep quality in these women. The primary objective is to measure sleep quality using several sleep-sp…

NCT07677709 — A Real-World Exploratory Study on the Sleep-Improving Efficacy of Dong’e Brand Ejiao Yuanjiang

This study employs a real-world design to evaluate the sleep-improving efficacy of Dong’e Brand Ejiao Yuanjiang. A total of 66 participants aged 25-55 will be enrolled and assessed after 60 days of continuous use.

Not Yet Recruiting

NCT07676292 — Effects of Sustainable Exercise Habits in University Students

This cross-sectional comparative study aims to evaluate the effects of sustainable exercise habits on cognitive awareness, body awareness, and sleep quality in university students.

The main hypotheses are:

H0: There is no difference in cognitive awareness, body awareness, and sleep quality between university students with sustainable exercise habits and those with a sedentary lifestyle.

H1: …

NCT07677384 — A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder

The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese adult participants with insomnia disorder.

NCT07667699 — Multidimensional Determinants of Functional Health In Women Aged 45-60

The goal of this observational study is to learn about the multidimensional determinants of functional health in women aged 45 to 60 years. The study will focus on the role of muscle strength, bone mineral density, body composition, physical activity, sleep quality, depressive symptoms, and menopause-related symptoms in functional health.

The main questions it aims to answer are:

1. Does musc…

NCT07683494 — Kinesiotape Versus Compression Stockings on Pregnant Leg Cramps and Sleep Quality

Kinesiotape versus compression stockings on pregnant leg cramps and sleep quality

NCT07678359 — Effect of ZenRest™ Lotus Seed & Rice Germ Extract Blend on Sleep Quality in Menopausal Women

The goal of this clinical trial is to learn if ZenRest™ (Lotus Seed & Rice Germ Extract Blend) can help improve sleep quality in menopausal women aged 40-65 with mild-to-moderate sleep complaints.

The main questions it aims to answer are:

• Does taking ZenRest™ daily improve subjective, participant-reported sleep quality compared to a placebo?
• Does ZenRest™ improve objective sleep metrics,…

NCT06045988 — Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer’s Disease

This study seeks to evaluate the utility and efficacy of the Non-Contact Sleep Quality Monitor System when used to monitor the sleep quality of individuals living in long-term care (LTC) with either Alzheimer’s Disease (AD) or Alzheimer’s Disease Related Dementia (ADRD). This before-after comparison trial will be conducted in several LTC facilities to evaluate the effect access to System Sleep …

NCT07553364 — Auditory Stimulation for Insomnia and Depression

The goal of this clinical trial is to determine if alpha phase-locked auditory stimulation can improve sleep in people with insomnia and depression. The main goals of the pilot study are the following:

Determine whether alpha phase-locked auditory stimulation (active stimulation) improves objective and subjective sleep in individuals with insomnia and depression.

The study team hypothesizes t…

NCT07677930 — Digital Insomnia and Circadian Therapy for Reducing Depression Symptoms in College Students

Depression is a leading cause of global disease burden, poor quality of life, disability and suicide, and commonly occurs in adolescence and early adulthood. Insomnia and circadian factors were regarded as potential targets for preventing worsening of depressive symptoms. Additionally, digital insomnia treatment reduces depressive symptoms but is insufficient for individuals with an evening chr…

NCT07672509 — Multimodal Sleep Promotion in Surgical ICU Patients

Sleep disturbances are highly prevalent among patients admitted to intensive care units (ICUs). Critical illness, environmental factors, and routine clinical care frequently result in fragmented sleep, reduced sleep quality, and disruption of normal circadian rhythms. Previous studies have shown that poor sleep in ICU patients may be associated with delirium, impaired recovery, decreased functi…

NCT05987007 — Sleep Interventions and Neurocognitive Outcomes

This protocol focuses on the effect of sleep interventions on improving sleep and building cognitive/brain resilience in older adults with amnestic mild cognitive impairment and sleep disturbance. Two sleep interventions, cognitive behavioral therapy for insomnia (CBTI) and acoustic slow-wave activity enhancement (SWAE), will be utilized in a pilot randomized clinical trial in which participant…

NCT06579183 — Pilot Trial for Health Products on Mood and Sleep Quality

This is a pilot, single-site clinical trial that will follow a randomized, double-blinded, parallel-group, placebo-controlled design. A total of 60 participants aged 18-65 will be recruited for a 12-week intervention, followed by a 4-week observational phase and a post-intervention visit at week 16. Participants will attend five scheduled visits at 4-week intervals (baseline, weeks 4, 8, 12, an…

NCT07674355 — Study of Sleep Quality and Its Specific Determinants During the Care Pathway of a Liver Transplant Patient

In the LIVERSLEEP study, investigators provide an overview of sleep disorders among patients in a liver transplantation (LT) pathway and a description of the criteria that can influence their sleep.

This is a prospective longitudinal monocentric pilot study, generating hypotheses whose main objective is to describe the evolution of sleep quality in LT patients between pre-LT evaluation (PLTE) …

NCT07686731 — Suvorexant 3 - PE-PC

The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumatic brain injury (TBI). The main questions it aims to answer are:

Does suvorexant, when combined w…

Enrolling by Invitation

NCT07409792 — Multifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes

The goal of this clinical trial is to evaluate whether the complementary intervention of auricular point sticking therapy (APST) can improve pregnancy outcomes by ameliorating psychological distress and sleep quality in female patients aged 20-45 years undergoing in-vitro fertilization and embryo transfer (IVF-ET) who also present with anxiety and/or insomnia.

The main questions it aims to ans…

NCT07566871 — Effect of Non-Invasive Vagus Nerve Stimulation in Burn Patients

This study will evaluate the effects of non-invasive vagus nerve stimulation (nVNS) in adults with burn injuries. Burn patients may experience anxiety, poor sleep quality, pain, itching, and changes in autonomic nervous system function during recovery.

Participants will be randomly assigned to one of two groups. The intervention group will receive conventional physiotherapy plus nVNS, and the …

NCT07566923 — Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients

This study will evaluate the effects of non-invasive vagus nerve stimulation in adolescents aged 12 to 18 years who have burn injuries. The study will include patients who have completed the acute phase after burn injury and who have symptoms such as anxiety, sleep problems, pain, or itching.

Participants will be randomly assigned to one of two groups. One group will receive conventional physi…

NCT07623889 — Rumination-Tailored Guided Internet-Based CBT-I for University Students

The goal of this clinical trial is to evaluate whether adding rumination-tailored, rule-based personalized feedback to guided internet-based cognitive behavioral therapy for insomnia (iCBT-I) improves treatment outcomes in university students with insomnia symptoms.

The main questions it aims to answer are:

Does rumination-tailored feedback improve insomnia severity compared to standard guide…

Completed Trials

NCT04054050 — Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

Sleep disturbance is common in people with multiple sclerosis (MS) and contributes to diminished quality of life. Bright light therapy may be an innovative strategy to reduce sleep disturbance in MS, possibly through its effects on a subtype of retinal ganglion cells that help regulate circadian rhythms and sleep. This pilot study will evaluate whether, in people with MS, bright light therapy r…

NCT05525637 — Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder

The main purpose of this study is to assess efficacy and safety of YZJ-1139 in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

NCT06094751 — An ACT Website for College Students With Insomnia

College students experience higher rates of insomnia compared the general population, and accessibility and availability for the appropriate intervention is difficult due limited resources available to them in a college environment. Theorefore, it is vital to offer an intervention that can be just as effective yet more accessible than other available treatments targeting insomnia. That is why t…

NCT05950646 — Mini-dose Dexmedetomidine-Esketamine Infusion and Perioperative Sleep Quality

Sleep disturbances are prevalent in older patients with osteoarthrosis or fracture who are scheduled for knee or hip replacement surgery. The occurrence of sleep disturbances is associated with worse outcomes including increased risk of delirium and cardiac events, and worsened functional recovery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, anxiolytic, and analge…

NCT07668609 — Storybook App vs Cognitive Behavioral Therapy for Child Sleep and Attachment

This completed randomized controlled trial compared two caregiver-delivered interventions for sleep in young children: a multimodal mobile health intervention delivered through the Storybook mobile application and a face-to-face psychoeducational intervention based on cognitive behavioral therapy principles. The study was conducted in Azuay Province, Ecuador.

Children aged 12 to 84 months were…

NCT06671444 — Pharmacokinetics and Safety Study of YZJ-1139 in Subjects With Severe Renal Impairment and Normal Renal Impairment

Objective：

1. To evaluate the pharmacokinetics of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.
2. To evaluate the safety of YZJ-1139 tablets in patients with severe renal impairment and in subjects with normal renal impairment.

NCT06671470 — A Drug-drug Interaction Study of YZJ-1139 Tablets and Ticagrelor Tablets in Healthy Subjects

Primary Objective :

To evaluate the effect of ticagrelor tablets on the pharmacokinetic characteristics of YZJ-1139 in healthy subjects;

Secondary Objective:

To evaluate the safety of ticagrelor tablets in combination with YZJ-1139 tablets in healthy subjects.

NCT06680531 — A Clinical Study to Evaluate the Drug Interaction Between YZJ-1139 Tablets and Escitalopram Oxalate Tablets

Primary Objective：

1) To evaluate the pharmacodynamic interaction between YZJ-1139 tablets and Escitalopram oxalate tablets in healthy subjects; 2) To evaluate the pharmacokinetic interaction between YZJ-1139 tablets and Escitalopram oxalate tablets in healthy subjects; To observe the safety of YZJ-1139 tablets taken together with Escitalopram oxalate tablets.

NCT06975514 — Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder

The main purpose of this study is to assess efficacy of YZJ-1139 for 28 days in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

NCT06755593 — Intravascular Laser and Electroacupuncture for Sciatica With Insomnia: A Pilot Trial

Sciatica is a common condition worldwide, with prevalence rates ranging from 1.2% to 43%. Chronic sciatica is often associated with sleep disturbances, forming a bidirectional loop where persistent nociceptive input disrupts sleep continuity, and sleep deprivation amplifies mechanical pain sensitivity. According to institutional records, sciatica accounts for approximately 26% of hospital admis…

NCT07681037 — The Impact of Good Versus Poor Sleep Quality on Quality of Life, Depression, and Fatigue in Individuals With Multiple Sclerosis

This cross-sectional study was conducted to examine the effects of good and poor sleep quality on quality of life, depression, and fatigue in individuals with multiple sclerosis.

The study was conducted at the Multiple Sclerosis (n=121) Outpatient Clinic of the Health Research and Application Center at the Trakya University between July 15, 2025, and December 30, 2025, with patients who were r…

NCT07069322 — The Role of Regional Analgesia in Sleep Quality

To evaluate the effect of regional analgesic blocks (TAP or rectus sheath block) applied in addition to general anesthesia on postoperative sleep quality in patients undergoing total abdominal hysterectomy (RCSQ score).

NCT06529120 — Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women With Breast Cancer Receiving Treatment in Rural Medically Underserved Areas

Women with breast cancer often experience multiple difficult symptoms, for example insomnia, fatigue, stress, and pain. This study is being done to test a mindfulness-based insomnia and symptom management intervention for women with breast cancer (Nite2Day). Participants will complete six, 45-60 minute intervention sessions with a study therapist. Intervention sessions will be conducted remotel…

NCT07667959 — The Effect of Benson Relaxation Exercise Applied to Cancer Patients on Sleep Quality

This is a study conducted to evaluate the effect of the Benson relaxation exercise on resolving sleep problems in cancer patients. It uses a randomized controlled pre-test/post-test design.

NCT07264114 — Aquatic High-Intensity Interval Training for Parkinson’s Disease

This randomized, single-center, parallel-group superiority trial will evaluate the effect of an 8-week aquatic High-Intensity Interval Training (HIIT) program on balance, physical function, and sarcopenia-related outcomes in individuals with Parkinson’s disease (PD). The intervention aims to deliver Tabata-style aquatic HIIT (3 sessions/week) in a therapeutic pool to determine adherence and pre…

NCT07511465 — Development, Sensory Profile, and Sleep Quality in Preschool Children Across Different Caregiving Models

This observational study aims to examine developmental status, sensory processing, and sleep quality in preschool children aged 3 to 6 years across different caregiving models. Children raised primarily by first-degree relatives, second-degree relatives, caregivers, or in daycare settings will be compared. Data will be collected using the Denver II Developmental Screening Test, the Dunn Sensory…

NCT07669766 — Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality

This study examines the effects of a plant-based phytomelatonin supplement compared to synthetic melatonin and placebo in adults with suboptimal sleep quality. The research uses a randomized, double-blind, placebo-controlled, three-arm clinical trial design. The primary aim is to determine whether phytomelatonin improves sleep outcomes compared to placebo and whether it matches or exceeds synth…

NCT07396779 — Cognitive Task-Based Walking Effects on Cognition, Mood, Sleep, and Quality of Life in Older Adults With Brain Fog

This randomized controlled trial aims to investigate the effects of cognitive task-based walking exercise on cognitive function, depressive symptoms, sleep quality, and quality of life in older adults experiencing brain fog. Eligible participants will be randomly assigned to either a cognitive task-based walking exercise group or a walking-only exercise group. The intervention will be conducted…

Other (Terminated)

NCT03436745 — The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females

Background:

Insomnia is associated with difficulty sleeping. The drug zolpidem is widely prescribed for insomnia. Women have reported worse effects from the drug than men. Women have higher amounts of zolpidem in their body that may persist after waking. Drug exposure may also depend on male hormones that change during prostate cancer therapy. Researchers want to see if these findings can prov…