Clinical trials: Sleep Disorders, Intrinsic
Insomnia
An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)
The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).
- Trial name
- NCT00103818
- Testing
- gaboxadol
- Volunteers
- 900 people
- Sponsor
- H. Lundbeck A/S
EDS, Cataplexy
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy…
- Conditions
- EDS, Cataplexy, Fatigue, Narcolepsy
- Trial name
- NCT07675135
- Testing
- HBS-301
- Where
- 53 sites in United States, Canada
- Volunteers
- 258 people
- Sponsor
- Harmony Biosciences Management, Inc.
Sleep-Disordered Breathing
Polysomnography Validation of the Sansa Device
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
- Trial name
- NCT06070389
- Testing
- Sansa device
- Where
- 2 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Huxley Medical, Inc.
Primary Insomnia
Polysomnography Study of MK-6096 in Participants With Primary Insomnia (MK-6096-011)
This was a cross-over, polysomnography (PSG) study to test the safety, tolerability and effectiveness of different doses of MK-6096 in the treatment of participants with primary insomnia.
- Trial name
- NCT01021852
- Testing
- MK-6096
- Volunteers
- 326 people
- Sponsor
- Merck Sharp & Dohme LLC
Idiopathic Hypersomnia
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years.
- Trial name
- NCT05156047
- Testing
- Open-label Pitolisant, Double-blind Pitolisant
- Where
- 58 sites in United States
- Volunteers
- 214 people
- Sponsor
- Harmony Biosciences Management, Inc.
Sleep Apnea, Sleep Apnea, Obstructive
Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Disorder, Sleep Apnea Syndromes
- Trial name
- NCT06283017
- Testing
- Hypoglossal nerve stimulation
- Where
- Australia
- Volunteers
- 14 people
- Sponsor
- Invicta Medical Inc.
Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Targeted Hypoglossal Neurostimulation Study #2
The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory
- Trial name
- THN2 (NCT01796925)
- Testing
- aura6000 THN System
- Where
- 9 sites in United States, Belgium and 3 more
- Volunteers
- 57 people
- Sponsor
- ImThera Medical, Inc.
Obstructive Sleep Apnea
Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing.
- Trial name
- NCT03579225
- Testing
- MATRx plus test
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zephyr Sleep Technologies
Sleep Apnea
Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders.
- Trial name
- VPASH (NCT04496843)
- Testing
- HWA09 Measurement
- Where
- 2 sites in Belgium, France
- Volunteers
- 220 people
- Sponsor
- Withings
Obstructive Sleep Apnea
Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion…
- Trial name
- NCT03122483
- Testing
- blood biomarker
- Where
- 3 sites in United States
- Volunteers
- 250 people
- Sponsor
- Beckman Coulter, Inc.
Obstructive Sleep Apnea
Developement of TipTraQ Home Sleep Test
The clinical study aims to develop and fine-tune the TipTraQ system, created by PranaQ, for home sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and…
- Trial name
- NCT06474351
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Insomnia, Sleep Disturbance
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Insomnia
Insomnia is known to be one of the most common health concerns in in the general population and has been associated with several health consequences.
- Trial name
- NCT04452981
- Testing
- VeNS
- Where
- 2 sites in Hong Kong, United Kingdom
- Volunteers
- 153 people
- Sponsor
- Neurovalens Ltd.
Pregnancy Related, Sleep
Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders
SLeeP AID4 is a single-group, single-arm, Canada-wide, non-randomised, unblinded, in-home, observational study to prospectively collect and build a data set of natural sleep behaviour and physiology in maternal-fetal dyads (and…
- Conditions
- Pregnancy Related, Sleep, Sleep-Disordered Breathing, Sleep Disturbance
- Trial name
- SLeeP AID4 (NCT05376475)
- Testing
- Infrared video-audio camera, Level III home sleep apnea test, Maternal-fetal transabdominal electrocardiographic heart rate monitor
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
IBS - Irritable Bowel Syndrome, Depression, Anxiety
The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome
This study aimed to assess the impact of consumption of COMBO, a combination product of two Bifidobacterium longum strains, on stress, mood and bowel symptoms in adults with Irritable Bowel Syndrome (IBS).
- Trial name
- IBS (NCT04422327)
- Testing
- Probiotic capsule
- Where
- Ireland
- Volunteers
- 40 people
- Sponsor
- PrecisionBiotics Group Ltd.
Obstructive Sleep Apnea
Pediatric Post-Approval Registry
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe…
- Trial name
- NCT04457154
- Testing
- Inspire Upper Airway Stimulation System
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- Inspire Medical Systems, Inc.
Pain, Back, Pain, Acute
Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches
This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive…
- Conditions
- Pain, Back, Pain, Acute, Sleep Disorder, Sleep Disorders, Circadian Rhythm
- Trial name
- RESTORE (NCT06505005)
- Testing
- Drug- free, non-invasive patch (FREEDOM or REM Patch) with haptic vibrotactile trigger technology (VTT) Other Names:
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- SuperPatch Limited LLC
Insomnia
PK/PD Study of YZJ-1139
Primary Objective： To determine the dose-response relationship of YZJ-1139 in young and elderly Chinese subjects after a single oral administration of different doses, and to compare it with zolpidem at clinical doses.
- Trial name
- NCT06685341
- Testing
- YZJ-1139, Zolpidem
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Posttraumatic Stress Disorder (PTSD), Sleep Disturbances and Insomnia
A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances
Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares.
- Trial name
- PTSD-PoC (NCT06685965)
- Testing
- RE03
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- Reconnect Labs
Chronic Insomnia
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia
- Trial name
- NCT02236845
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Lacrima Medical LTD
Sleep Disorder
A Clinical Study on the Improvement of Sleep Quality, Skin Condition and Life Status After Taking Sleep Aid Drinks
The main objective of the study is to observe changes in the subjects' sleep quality, skin condition and life status after 4 weeks of using a sleep aid drink (AOXMED Poria γ-aminobutyric acid drink).
- Trial name
- NCT05908903
- Testing
- Drinks with active ingredients such as poria and GABA
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Botanee Group Co., Ltd.
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