Clinical trials: Sleep Disorders, Intrinsic
Central Sleep Apnea
remedē System Therapy Study
The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.
- Trial name
- rēST (NCT03884660)
- Testing
- remede System
- Where
- 32 sites in United States, Netherlands
- Volunteers
- 225 people
- Sponsor
- Respicardia, Inc.
Insomnia
Combined Effects of Prunus Cerasus and Apocynum Venetum On Sleep and Anxiety in Adults With Insomnia
Lay Summary: This study is about the effect of using a unique formula called Sip2Sleep®, a product currently available on the market which is a combination of montmorency tart cherry extract and Venetron® (Apocynum venetum leaf…
- Trial name
- Sip2Sleep (NCT06299488)
- Testing
- Sip2Sleep: Montmorency Cherry and Apocynum Venetum
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- Lakshmi Nutraceuticals LLC
Restless Legs Syndrome
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome
Prospective multi-site randomized sham-controlled crossover feasibility study evaluating tolerability and efficacy of noninvasive peripheral nerve stimulation (NPNS) for patients with moderate-severe primary Restless Legs…
- Trial name
- NCT04700683
- Testing
- Noctrix Health NPNS device v1.0 - Active
- Where
- 3 sites in United States
- Volunteers
- 43 people
- Sponsor
- Noctrix Health, Inc.
Sleep Apnea, Sleep Apnea, Obstructive
A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (Neural and/or Muscular) for the Treatment of Obstructive Sleep Apnea
This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06627127
- Testing
- Target stimulation (HGN, AC, GG, Strap muscles)
- Where
- 4 sites in Australia
- Volunteers
- 35 people
- Sponsor
- Invicta Medical Inc.
Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal)
Rhythm Express Wearable System vs. Simultaneous Polysomnography for the Diagnosis of Obstructive Sleep Apnea in Adults With Suspected or Observed Atrial Fibrillation
The goal of this observational study is to confirm the accuracy of the sleep algorithm (software) used in the Rhythm Express Wearable System to detect sleep apnea severity.
- Conditions
- Obstructive Sleep Apnea (OSA), Atrial Fibrillation (Paroxysmal), Palpitations
- Trial name
- NCT06907888
- Testing
- Rhythm Express Wearable System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- VivaQuant
Obstructive Sleep Apnea
The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea
This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee mask amongst Obstructive Sleep Apnea (OSA) patients.
- Trial name
- NCT03726346
- Testing
- Toffee Full Face Mask
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA…
- Trial name
- NCT03075722
- Testing
- Saturn nasal mask
- Where
- New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Clinical Evaluation of a Wearable Sleep Diagnosis Technology
The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.
- Trial name
- NCT03544086
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Acurable Ltd.
Insomnia
An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)
A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).
- Trial name
- NCT00102154
- Testing
- MK0928, gaboxadol / Duration of Treatment: 10 months
- Volunteers
- healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Primary Insomnia, Secondary Insomnia
An Efficacy Study of Compound LY2624803 in the Treatment of Patients With Chronic Insomnia
The purpose of this study is to compare an investigational drug (LY2624803) with placebo and with zolpidem in the treatment of outpatients with chronic insomnia.
- Trial name
- SLUMBER (NCT00784875)
- Testing
- LY2624803, zolpidem
- Where
- 49 sites in United States
- Volunteers
- 643 people
- Sponsor
- Eli Lilly and Company
Insomnia Disorder
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.
- Trial name
- NCT05525637
- Testing
- YZJ-1139 20mg, YZJ-1139 40mg
- Where
- 83 sites in China
- Volunteers
- 1,037 people
- Sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Restless Legs Syndrome
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.
- Trial name
- NCT02658188
- Testing
- ASP8825
- Where
- 10 sites in Japan
- Volunteers
- 182 people
- Sponsor
- Astellas Pharma Inc
Obstructive Sleep Apnea, OSA
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).
- Trial name
- NCT05881512
- Testing
- Transcutaneous Upper Airway Stimulation Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Somnial Inc
Narcolepsy
Safety and Efficacy of Xyrem Oral Solution (Sodium Oxybate) Compared With Placebo in Narcoleptic Patients
The initial portion of the protocol involves discontinuing any medications for cataplexy that the patient may be taking. Subsequently, the patient is prescribed a dose of oral solution of study drug or placebo over a 10-11 week…
- Trial name
- NCT00049803
- Testing
- sodium oxybate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 200 people
- Sponsor
- Orphan Medical
OSA - Obstructive Sleep Apnea
Parallel Arm Trial of AD109 and AD504 In Patients With OSA
This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
- Trial name
- MARIPOSA (NCT05071612)
- Testing
- AD109, AD504, Atomoxetine Hydrochloride
- Where
- 25 sites in United States
- Volunteers
- 294 people
- Sponsor
- Apnimed
Obstructive Sleep Apnea (OSA)
Study of Min-Max APAP Recommender Tool
Pressure Match (The APAP Min-Max tool) is a software-based clinical decision-support tool, developed using a causal-inference modelling approach based on data from thousands of OSA patients.
- Trial name
- SMART (NCT07400861)
- Testing
- CPAP with min-max recommender tool, CPAP with default settings
- Where
- Australia
- Volunteers
- 90 people
- Sponsor
- ResMed
Insomnia, Sleeplessness
Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness
The purpose of this study is to determine whether a small electrical current to the vestibular nerve (balance organ) will decrease the time it take for participants to fall asleep.
- Conditions
- Insomnia, Sleeplessness, Transient Insomnia
- Trial name
- VSOM (NCT00594022)
- Testing
- Electric stimulation of the Vestibular Nerve - "VirtuSom"
- Where
- 6 sites in United States
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Insomnia
Evaluation of an Oral Cannabidiol (CBD)-Terpene Formulation on Sleep Physiology in Participants With Insomnia
Insomnia is a disorder in which people have inadequate or poor-quality sleep due to a number of factors, such as difficulty falling asleep, waking up frequently during the night with difficulty returning to sleep, waking up too…
- Trial name
- NCT05233761
- Testing
- Defined CBD
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Defined Research
Obstructive Sleep Apnea
Severe Label Expansion for EVO Products Trial
Title: Severe Label Expansion for EVO Positioner (SLEEP) Study Description: Single-arm study to determine the safety and effectiveness of treating severe obstructive sleep apnea using the EVO Sleep and Snore Device (ProSomnus…
- Trial name
- SLEEP (NCT07090395)
- Testing
- EVO Sleep and Snore Device
- Where
- 2 sites in United States
- Volunteers
- 49 people
- Sponsor
- ProSomnus Sleep Technologies
Narcolepsy With Cataplexy
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.
- Trial name
- NCT02221869
- Testing
- Xyrem
- Where
- 20 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Jazz Pharmaceuticals
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