Clinical trials: Dyssomnia
Obstructive Sleep Apnea
Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the HGNS System for stimulating the hypoglossal nerve to help maintain an open airway in subjects with obstructive sleep apnea (OSA).
- Trial name
- NCT01186926
- Testing
- HGNS Treatment
- Volunteers
- 40 people
- Sponsor
- Apnex Medical, Inc.
Post-Concussion Symptoms, Insomnia
Neurotechnology Following Traumatic Brain Injury
This two-part study seeks to improve symptoms such as pain and sleep problems after concussion, or mild traumatic brain injury (mTBI).
- Conditions
- Post-Concussion Symptoms, Insomnia, Pain, Chronic, Depressive Symptoms
- Trial name
- Cereset (NCT03649958)
- Testing
- HIRREM-SOP or Cereset, Cereset 2x
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Brain State Technologies, LLC
Primary Insomnia
A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia
The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.
- Trial name
- NCT00551148
- Testing
- PD 0200390
- Where
- 16 sites in United States
- Volunteers
- 92 people
- Sponsor
- Pfizer
Restless Leg Syndrome (RLS)
Observe Change in Nasal Swab DRD2 Gene Expression in Restless Legs Syndrome (RLS) Patients on Prolonged Dopamine Agonist Treatment
The study aims to observe changes in dopaminergic genes expression in peripheral tissue upon prolonged dopamine agonist treatment on patients with Restless Legs Syndrome (RLS).
- Trial name
- RLS-DRD2gene (NCT06726785)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HBC Immunology Inc
Sleep Apnea, Obstructive
A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.
- Trial name
- NCT03796026
- Testing
- Seltorexant 40 mg
- Where
- 4 sites in United States
- Volunteers
- 34 people
- Sponsor
- Janssen Research & Development, LLC
Insomnia Disorder
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective…
- Trial name
- NCT02952820
- Testing
- lemborexant
- Where
- 114 sites in United States, Canada and 10 more
- Volunteers
- 971 people
- Sponsor
- Eisai Inc.
Obstructive Sleep Apnea
Trial of AD036 in Obstructive Sleep Apnea
This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with…
- Trial name
- NCT03845023
- Testing
- AD036 Dose 1, AD036 Dose 2, AD036 Dose 3
- Where
- 12 sites in United States
- Volunteers
- 140 people
- Sponsor
- Apnimed
Insomnia Disorders
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users
The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and…
- Trial name
- NCT03158025
- Testing
- Zolpidem tablets, Suvorexant tablets, over-encapsulated, Lemborexant tablets
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
OSA
Continuation Protocol for Obstructive Sleep Apnea (OSA)
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA).
- Trial name
- NCT06566820
- Testing
- Aroxybutynin and Atomoxetine
- Where
- 99 sites in United States, Canada
- Volunteers
- 1,280 people, healthy volunteers welcome
- Sponsor
- Apnimed
Snoring, Obstructive Sleep Apnea
Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or…
- Trial name
- NCT03510403
- Testing
- nastent™
- Where
- 6 sites in France
- Volunteers
- 32 people
- Sponsor
- Seven Dreamers Europe SAS
Obstructive Sleep Apnea
Reiterative Development and Evaluation Study of OSA Therapy System
The purpose of this study is to evaluate new iterations/generations of the ApniCure sleep therapy device.
- Trial name
- NCT01634074
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- ApniCure, Inc.
Restless Legs Syndrome
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS).
- Trial name
- NCT01498120
- Testing
- Rotigotine
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Insomnia
Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
To demonstrate overall improvement of insomnia in subjects treated with zolpidem tartrate extended-release (Ambien CR) and escitalopram (Lexapro) vs. subjects treated with placebo and escitalopram at 2 months.
- Trial name
- NCT00296179
- Testing
- zolpidem tartrate
- Volunteers
- 372 people
- Sponsor
- Sanofi
Obstructive Sleep Apnea
Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea
The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous…
- Trial name
- TESLA-MICRON (NCT07343362)
- Testing
- ZeusOSA, CPAP
- Volunteers
- 186 people
- Sponsor
- Zeus Sleep Ltd
Obstructive Sleep Apnea
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system.
- Trial name
- NCT02255539
- Testing
- Geelong Prototype Mask
- Where
- Australia
- Volunteers
- 42 people
- Sponsor
- ResMed
Sleep Initiation and Maintenance Disorders
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release) 12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with primary insomnia and sleep maintenance…
- Trial name
- NCT00630175
- Testing
- zolpidem-MR (modified release), zolpidem (SL800750)
- Where
- 3 sites in United States, Australia and 1 more
- Volunteers
- 113 people
- Sponsor
- Sanofi
Narcolepsy, Obstructive Sleep Apnea
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.
- Trial name
- NCT02348632
- Testing
- JZP-110
- Where
- 80 sites in United States, Canada and 4 more
- Volunteers
- 645 people
- Sponsor
- Jazz Pharmaceuticals
Restless Legs Syndrome
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
This is a multi-center, open-label extension trial conducted at the same European sites that participated in trial SP 709 (NCT00243217).
- Trial name
- NCT00498186
- Testing
- Rotigotine
- Where
- 24 sites in Austria, Germany and 1 more
- Volunteers
- 295 people
- Sponsor
- UCB Pharma
Sleep Apnea, Obstructive, Obstructive Sleep Apnea Syndrome
Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk
The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk.
- Trial name
- TELESAS (NCT01226641)
- Testing
- Telemedicine, Standard care
- Where
- 14 sites in France
- Volunteers
- 107 people
- Sponsor
- Initiative Pour la Sante
Obstructive Sleep Apnea
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask
- Trial name
- NCT02972970
- Testing
- Aveera
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Metamason
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