Clinical trials: Sleep Disorders, Intrinsic
Obstructive Sleep Apnea
A Comparison of CPAP With and Without Humidification: A Pilot Study
To compare a group of patients with our standard treatment of continuous positive airway pressure (CPAP) and another group of patients with CPAP and a humidifier attached.
- Trial name
- NCT02423681
- Testing
- ThermoSmart, Without ThermoSmart
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Validation of an Integrated Digital Solution (SUNrise®) Versus Polysomnography for Obstructive Sleep Apnea Diagnosis
Validation of an integrated digital solution (SUNrise®) of mandibular movement automatic analysis by artificial intelligence versus polysomnography for obstructive sleep apnea diagnosis: a prospective, randomized, parallel-arm…
- Trial name
- SUNSAS (NCT05057975)
- Testing
- Sunrise, polysomnography
- Where
- 19 sites in France
- Volunteers
- 848 people, healthy volunteers welcome
- Sponsor
- Sunrise
Obstructive Sleep Apnea
RPMO2 Oximeter Accuracy During Sleep 1 Trial
The goal of this observational study is to validate the accuracy of the RPMO2 OSA Device's oxygen desaturation index in individuals with obstructive sleep apnea versus the gold standard, in-lab polysomnography.
- Trial name
- ROADS-1 (NCT07397780)
- Testing
- RPMO2 OSA Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ProSomnus Sleep Technologies
Obstructive Sleep Apnea
Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea
The aim of this study is to assess the efficacy of transcutaneous electrical stimulation of the upper airway muscles in patients with obstructive sleep apnea.
- Trial name
- NCT04932486
- Testing
- Transcutaneous electrical stimulation
- Where
- Belgium
- Volunteers
- 42 people
- Sponsor
- Sunrise
Sleep Apnoea
Ventricular Arrhythmias Incidence According to Sleep Apnea Syndrome in Implantable Cardioverter-Defibrillator (ICD) Patients
The purpose of this study is to report the incidence of ventricular arrhythmias correlated to the SAS and to focus on the interest of diagnosing Sleep-disorders breathing in ICD patients.
- Trial name
- NCT00708786
- Testing
- ICD, CRT-D
- Where
- 31 sites in France, Germany and 2 more
- Volunteers
- 755 people
- Sponsor
- LivaNova
Sleep, Relaxation
Sleep and Morning Wellbeing Study
The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 30 days. The subjects will complete questionnaires throughout the study at pre-specified timepoints.
- Conditions
- Sleep, Relaxation, Stress, Daytime Sleepiness
- Trial name
- NCT07311434
- Testing
- Sleep Supplement
- Where
- United States
- Volunteers
- 331 people, healthy volunteers welcome
- Sponsor
- Athletic Greens International
Obstructive Sleep Apnea
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an…
- Trial name
- NCT04718142
- Testing
- vNEP
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Somne, LLC
Restless Legs Syndrome
12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects
The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.
- Trial name
- NCT01061372
- Testing
- pregabalin
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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, Generalized Anxiety Disorder
Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder.
- Trial name
- NCT00235508
- Testing
- Eszopiclone (Lunesta)
- Where
- 64 sites in United States
- Volunteers
- 420 people
- Sponsor
- Sumitomo Pharma America, Inc.
Apnea, Sleep
Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)
This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal…
- Trial name
- NCT01092780
- Testing
- MK-7288, Modafinil
- Volunteers
- 56 people
- Sponsor
- Merck Sharp & Dohme LLC
Excessive Daytime Sleepiness, Parkinson Disease
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness
This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with…
- Trial name
- CASPAR (NCT03194217)
- Testing
- BEN-2001
- Where
- United States
- Volunteers
- 244 people
- Sponsor
- BenevolentAI Bio
Chronic Insomnia
Comparing Insomnia Care As Usual to Digital Augmentation (CICADA)
The purpose of this pragmatic non-inferiority randomized clinical trial is to evaluate whether Cognitive Behavioral Treatment of Insomnia (CBTI) delivered through a clinical decision support digital platform is non-inferior to…
- Trial name
- NCT05490550
- Testing
- COAST-enhanced CBTI, Military Treatment Facility Insomnia Care As Usual
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- Noctem, LLC
Restless Legs Syndrome, Restless Legs Syndrome (RLS)
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
- Trial name
- NCT00314860
- Testing
- ropinirole Extended Release (XR)
- Where
- 91 sites in United States, Australia and 11 more
- Volunteers
- 568 people
- Sponsor
- GlaxoSmithKline
Sleep Apnea, Obstructive
Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal.
- Trial name
- NCT01517750
- Testing
- ICON Auto CPAP™ with Thermosmart heated tube, ICON Auto CPAP™ without Thermosmart heated tube
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Stimulation Therapy for Apnea Reduction (Www.theSTARtrial.Com)
The purpose of this clinical trial is to demonstrate long-term safety and efficacy of the Inspire system. The Inspire Upper Airway Stimulation (UAS) therapy is intended to treat moderate-to-severe obstructive sleep apnea by…
- Trial name
- STAR (NCT01161420)
- Testing
- Inspire Upper Airway Stimulation System
- Where
- 22 sites in United States, Belgium and 3 more
- Volunteers
- 929 people
- Sponsor
- Inspire Medical Systems, Inc.
Insomnia
A Study of Suvorexant (MK-4305) for the Treatment of Insomnia Disorder in Participants With Opioid Use Disorder (MK-4305-098)
People with opioid use disorder (OUD) can have trouble falling or staying asleep. Researchers want to know if suvorexant will help people with OUD fall asleep and stay asleep.
- Trial name
- NCT06655883
- Testing
- Suvorexant
- Where
- 13 sites in United States
- Volunteers
- 300 people
- Sponsor
- Merck Sharp & Dohme LLC
Narcolepsy Type 2
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.
- Trial name
- Vibrance-2 (NCT06555783)
- Testing
- ALKS 2680
- Where
- 47 sites in United States, Australia and 6 more
- Volunteers
- 93 people
- Sponsor
- Alkermes, Inc.
Sleep Initiation and Maintenance Disorders
15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.
Subjects will be screened within 28 days, Simvastatin dose and single SB-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days SB-649868 repeat dosing with safety and cognition function tests.
- Trial name
- NCT00495729
- Testing
- SB-649868, Simvastatin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Anxiety, Depression
Comparison of MMFS Dosages in Older Adults
This study is designed to compare the effectiveness of different doses of brain health supplement MMFS relative to placebo on cognition, mood, and sleep quality.
- Conditions
- Anxiety, Depression, Sleep Quality, Cognitive Impairment
- Trial name
- NCT03601169
- Testing
- Low Dose MMFS-205-SR, High Dose MMFS-205-SR
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Neurocentria, Inc.
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