Clinical trials: Sleep Disorders, Intrinsic
Restless Legs Syndrome
Safety and Efficacy Study of IPX159 in Restless Legs Syndrome (RLS)
The purpose of this study is to determine whether IPX159 is safe and effective in treating symptoms of RLS in subjects with Restless Legs Syndrome.
- Trial name
- NCT01521663
- Testing
- IPX159
- Where
- 38 sites in United States
- Volunteers
- 159 people
- Sponsor
- Impax Laboratories, LLC
Right to Left Shunt, Patent Foramen Ovale
Right to Left Cardiac Shunt Detection
The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to the results of transesophageal…
- Conditions
- Right to Left Shunt, Patent Foramen Ovale, Atrial Septal Defect
- Trial name
- PFO Detection (NCT01773252)
- Testing
- Flow Detection System
- Where
- 8 sites in United States
- Volunteers
- 141 people
- Sponsor
- Cardiox Corporation
Restless Legs Syndrome
Noninvasive Peripheral Nerve Stimulation for Medication-Refractory Primary RLS (The RESTFUL Study)
Multi-center, prospective double-blind randomized controlled pivotal study of noninvasive peripheral nerve stimulation (NPNS) with the NTX100 Neuromodulation System for patients with medication-refractory moderate-severe primary…
- Trial name
- NCT04874155
- Testing
- NTX100 Neuromodulation System - Active, NTX100 Neuromodulation System - Open-Label
- Where
- 7 sites in United States
- Volunteers
- 133 people
- Sponsor
- Noctrix Health, Inc.
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
Chronic Insomnia
Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
- Trial name
- NCT05456152
- Testing
- Sublingual Tablet
- Where
- Brazil
- Volunteers
- 358 people
- Sponsor
- EMS
Insomnia
Investigation of the Efficacy and Safety of CHI-921 in Insomnia.
Insomnia is a disorder where people are having trouble sleeping and can include difficulty falling asleep, staying asleep and waking up too early, as well as having unrefreshing sleep.
- Trial name
- NCT03984604
- Testing
- CHI-921
- Where
- Canada
- Volunteers
- 21 people
- Sponsor
- Canopy Growth Corporation
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
Sleep Disordered Breathing, Obstructive Sleep Apnea
An Investigation to Test a Prototype Full-face Mask in the Home Setting
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter…
- Trial name
- NCT02938208
- Testing
- Jupiter Full Face Mask
- Where
- 2 sites in New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
Insomnia
Safety and Pharmacokinetic Study of Sublingual Flumazenil (CRLS035) in Healthy Adults
This study compare the pharmacokinetic (PK) profile of sublingual CRLS035 (two doses) to I.V flumazenil administration. Selection of study drug dosage: CRLS035 - sublingual Flumazenil will be administrated at a final dosage of…
- Trial name
- NCT01655914
- Testing
- Flumazenil
- Where
- Israel
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Coeruleus Ltd.
Sleep, Wearable Technology
Effects of PeptiSleep on Sleep Quality in Healthy Adults
Examining the effects of PeptiSleep, a plant-based sleep aid, on sleep quality in healthy adults
- Conditions
- Sleep, Wearable Technology, Cortisol, Healthy Participants
- Trial name
- NCT07258433
- Testing
- PeptiSleep, Micro-crystalline cellulose
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nuritas Ltd
Restless Legs Syndrome
A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
- Trial name
- NCT00625547
- Testing
- cabergoline, levodopa
- Where
- 50 sites in Austria, Germany and 2 more
- Volunteers
- 361 people
- Sponsor
- Pfizer
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
The goal of this observational study is to collect information on the safety and performance of the remedē System in patients with central sleep apnea who are undergoing the remedē System implant procedure.
- Conditions
- Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea, Phrenic Nerve Stimulation
- Trial name
- ROSTER (NCT07907068)
- Testing
- Phrenic nerve stimulation
- Volunteers
- 300 people
- Sponsor
- Zoll Medical Corporation
Atrial Fibrillation, Obstructive Sleep Apnea
The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA
This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive…
- Trial name
- AFOSA (NCT04519489)
- Testing
- PAP therapy with telemonitoring, AF standard management and OSA general care
- Where
- 2 sites in China
- Volunteers
- 129 people
- Sponsor
- Philips (China) Investment CO., LTD
Sleep Apnea, Obstructive
The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System
The objective of the study is to assess the effectiveness of the Aspire Medical Advance System in obstructive sleep apnea by demonstrating a statistically significant mean reduction in the apnea-hypopnea index (AHI) from baseline…
- Trial name
- NCT00467324
- Testing
- Aspire Medical Advance System
- Where
- 4 sites in United States
- Volunteers
- 42 people
- Sponsor
- Aspire Medical
Obstructive Sleep Apnea
Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy.
- Trial name
- NCT01421654
- Testing
- S9 Elite with Acclimate, S9 Elite
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ResMed
Sleep Apnea Syndrome
Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)
The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.
- Trial name
- NCT00942669
- Testing
- SleepStrip OTC(TM)
- Where
- Israel
- Volunteers
- 80 people
- Sponsor
- Scientific Laboratory Products, Ltd.
Obstructive Sleep Apnea (OSA)
Vent Flow Study of Prototype Nasal CPAP Mask
As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology.
- Trial name
- GVFECT (NCT02805777)
- Testing
- CPAP mask
- Sponsor
- ResMed
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.
Obstructive Sleep Apnea
PAP Systems External Clinical Studies (ECS)
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
- Trial name
- NCT06562205
- Testing
- PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed
Sleep Apnea Syndromes
Efficacy Investigation of the Medical Device Apneal® on Smartphone for Sleep Apnea-Hypopnea Syndrome Diagnosis
The goal of this clinical trial is to evaluate the effectiveness of the Apneal® app in diagnosing sleep apnea syndrome (SAS) in adults who require polysomnography (PSG) as part of routine care.
- Trial name
- SESAME (NCT06578390)
- Testing
- Apneal device
- Where
- 11 sites in France
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Mitral