Clinical trials: Dyssomnia
Obstructive Sleep Apnea
A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
- Trial name
- NCT03272763
- Testing
- F&P Toffee mask
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Fisher and Paykel Healthcare
Adult Nocturnal Enuresis, Urinary Incontinence (UI)
This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.
This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their…
- Trial name
- PUREST (NCT06666426)
- Testing
- PureWick System, Hollister Female Urinary Pouch External Collection Device
- Where
- 15 sites in United States
- Volunteers
- 171 people
- Sponsor
- C. R. Bard
Healthy
Lavender Essential Oil-based Product System for Sleep
The goal of this clinical trial is to learn whether lavender essential oil-based product system can affect gene expression, serum protein markers, and sleep quality in healthy volunteers.
- Trial name
- NCT06510335
- Testing
- Lavender essential oil-based product system
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- dōTERRA International
Narcolepsy Type 1
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- NCT07540897
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 20 sites in United States, Belgium and 3 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Obstructive Sleep Apnea (OSA)
Safety and Tolerability of Gefapixant (MK-7264) in Participants With Obstructive Sleep Apnea (MK-7264-039)
The purpose of this study is to assess the safety and tolerability of multiple dose administration of gefapixant (MK-7264) in participants with moderate to severe obstructive sleep apnea (OSA).
- Trial name
- NCT03882801
- Testing
- Gefapixant
- Where
- 5 sites in United States, Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Restless Legs Syndrome
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and…
- Trial name
- NCT03728933
- Testing
- Rotigotine 1 milligram/24 hours, Rotigotine 2 milligram/24 hours
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- UCB Biopharma SRL
INSOMNIA
A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.
- Trial name
- Eszo (NCT01100164)
- Testing
- Eszopiclone, Zopiclone
- Where
- Brazil
- Volunteers
- 263 people
- Sponsor
- Eurofarma Laboratorios S.A.
Restless Legs Syndrome
Iron Sucrose In The Treatment of Restless Legs Syndrome: Safety of Three Dose Regimens as Evaluated by Clinical Assessments
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of 3 treatment cohorts.
- Trial name
- NCT00895232
- Testing
- Cohort I, Cohort II, Cohort III
- Volunteers
- 21 people
- Sponsor
- American Regent, Inc.
Sleep Apnea, Obstructive
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with obstructive sleep…
- Trial name
- NCT00107809
- Testing
- Modafinil
- Where
- 64 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Sleep Apnea, Stroke
Non-contact Sleep Apnea Identification in Neurological Rehabilitation
To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard…
- Trial name
- NCT04803552
- Testing
- Overnight sleep study with Sleepiz One and a respiratory polygraphy
- Where
- Switzerland
- Volunteers
- 67 people
- Sponsor
- Sleepiz AG
Sleep Apnea
Clinical Evaluation of a Paediatric Sleep Diagnosis Technology
The objective of this project is to gather research data and subsequently evaluate algorithms to demonstrate clinical efficacy of a novel sleep apnoea detection system in the paediatric population.
- Trial name
- NCT04031950
- Testing
- Novel wearable paediatric device
- Where
- 2 sites in United Kingdom
- Volunteers
- 200 people
- Sponsor
- Acurable Ltd.
Obstructive Sleep Apnea
TheraPAP Equivalence Crossover Study
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
- Trial name
- NCT06238362
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- SleepRes Inc.
Sleep, Insomnia
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation.
- Conditions
- Sleep, Insomnia, Sleep Apnea Syndrome, Obstructive
- Trial name
- NCT04943562
- Testing
- ACT+EEG
- Where
- 2 sites in Brazil
- Volunteers
- 96 people
- Sponsor
- SleepUp Tecnologia em Saúde Ltda
Obstructive Sleep Apnea, Sleep Apnea
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
- Trial name
- CO-STAR (NCT05608486)
- Testing
- aerSleep II
- Sponsor
- Sommetrics, Inc.
Insomnia
A Six Week, Double-Blind Randomized, Efficacy and Safety, Sleep Lab Trial With Esmirtazapine (Org 50081) (P05707)
The purpose of this trial is to investigate the efficacy, safety and tolerability of esmirtazapine (Org 50081) compared to placebo in patients with chronic primary insomnia.
- Trial name
- NCT00506389
- Testing
- Esmirtazapine
- Volunteers
- 419 people
- Sponsor
- Merck Sharp & Dohme LLC
Shift Work Sleep Disorder, Shift Work Type Circadian Rhythm Sleep Disorder
Recovery and Early Sleep Tracking Using the SuperPatch REM Patch
A Phase 1 Feasibility Study of the SuperPatch REM Patch for Post-Night-Shift Sleep Recovery in NHS Doctors
- Conditions
- Shift Work Sleep Disorder, Shift Work Type Circadian Rhythm Sleep Disorder, Shift Work Sleep Disorders
- Trial name
- REST (NCT07785960)
- Testing
- SuperPatch REM Patch
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- SuperPatch Limited LLC
Sleep Disordered Breathing, Congestion, Nasal
To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic…
- Trial name
- NCT03105297
- Testing
- Prototype nasal dilator strip, No strip
- Where
- Australia
- Volunteers
- 91 people
- Sponsor
- GlaxoSmithKline
Bladder Function
Pilot Trial in Sleep Laboratory Setting to Compare the Physiology of Night Time Bladder Function in Subjects With Overactive Bladder (OAB) Versus Subjects That Have Insomnia and Healthy Normal Subjects
This is an observational, physiology pilot study of subjects with overactive bladder, insomnia and normal subjects. No study drug will be given. All subjects will complete a one week sleep diary and a 3-day bladder diary.
- Trial name
- Nocturia Plt 1 (NCT01029015)
- Testing
- cystometry, polysomnography
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Sleep Apnea, Obstructive
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard…
- Trial name
- NCT01517763
- Testing
- Conventional CPAP Therapy, Fixed pressure ICON™ without ThermoSmart™, Auto ICON™ with SensAwake™ and ThermoSmart™
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea Syndromes
Sleep Disordered Breathing and Chronic Pain
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.
- Trial name
- NCT01457014
- Testing
- servo ventilation auto, Continuous positive airway pressure, servo ventilation manual
- Where
- 4 sites in United States
- Volunteers
- 88 people
- Sponsor
- Philips Respironics
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