Clinical trials: Sleep Disorders, Intrinsic
Insomnia (moderate)
Impact of GABA Probiotic Lactiplantibacillus Plantarum Lp815 on Sleep Outcomes in Participants with Self-Reported Sleep Disturbance
The rationale for this study is to observe differences in sleep outcomes between a consumer-grade probiotic capsule called GABA Probiotic and a placebo control group.
- Trial name
- NCT06789718
- Testing
- GABA Probiotic Lactiplantibacillus plantarum Lp815 (5 Billion cfu/dose), Optional Sub-Study: Neurotransmitter Urine Test
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Verb Biotics LLC
Obstructive Sleep Apnea (OSA) and Obesity
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Receiving Positive Airway Pressure (PAP) Therapy
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity receiving positive airway pressure (PAP)…
- Trial name
- NCT07794397
- Testing
- HDM1005
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea
Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea…
- Conditions
- Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH
- Trial name
- AERO C009E (NCT00849043)
- Where
- 13 sites in United States
- Volunteers
- 65 people
- Sponsor
- Ventus Medical, Inc.
Sleep, Sleep Quality
The Effects of a Nutritional Supplement on Sleep Quality
This study is a randomized, double-blind, placebo-controlled study of N=140 adult men and women with sub-clinical sleep issues. This study to assess the effect of a novel dietary supplement on sleep related outcomes.
- Trial name
- NCT07345260
- Testing
- Novel powdered sleep supplement
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Athletic Greens International
Obstructive Sleep Apnea
Field Usability Study of Eclipse Mask
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05559047
- Testing
- Eclipse mask
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea
A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
- Trial name
- EliSA (NCT04031040)
- Testing
- Genio® system therapy
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Nyxoah S.A.
Restless Legs Syndrome
Specified Drug Use-Results Survey of Regnite
This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.
- Trial name
- NCT01887613
- Testing
- Regnite
- Where
- 7 sites in Japan
- Volunteers
- 1,597 people
- Sponsor
- Astellas Pharma Inc
Sleep Apnea, Obstructive, Sleep Apnea, Central
DreamKit Diagnostic Validation
This study has been developed in order to demonstrate diagnostic efficacy of the DreamKit device against polysomnography.
- Trial name
- NCT04671342
- Testing
- DreamKit
- Where
- 7 sites in United States
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Obstructive Sleep Apnea
Efficacy and Compliance of the Mandibular Advancement Devices ONIRIS® vs. Custom Made Devices
To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use.
- Trial name
- IRIS (NCT02348970)
- Testing
- ONIRIS®, TALI
- Where
- 10 sites in France
- Volunteers
- 211 people
- Sponsor
- ONIRIS
Insomnia
Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -
The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.
- Trial name
- NCT02153086
- Testing
- Ramelteon
- Where
- 2 sites in Japan
- Volunteers
- 236 people
- Sponsor
- Takeda
Heart Failure, Central Sleep Apnea
Cardiac Resynchronisation Therapy in Combination With Overdrive Pacing in the Treatment of Central Sleep Apnea in CHF
The primary objective of this study is to compare the Apnea- Hypopnea Index in HF patients with concomitant CSA, after 12 weeks of CRT alone to CRT in combination with one night of overdrive pacing.
- Trial name
- Morpheus (NCT00551499)
- Testing
- CRT + AOP
- Where
- 2 sites in Germany
- Volunteers
- 44 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Obstructive Sleep Apnea (OSA), Positional Obstructive Sleep Apnea
Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea
Patients with obstructive sleep apnea (OSA) often experience more frequent and severe breathing disturbances when sleeping in the supine (back-sleeping) position compared with non-supine positions.
- Trial name
- NCT07714330
- Testing
- Investigational Positional Therapy Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SleepDev, Inc
Apnea, Obstructive
Study Evaluating the Effect of a Specific Trace Metal Complex Versus Placebo on the Severity of Apnea in Patients With Obstructive Sleep Apnea Syndrome
Obstructive sleep apnea syndrome (OSA) is defined by the association of clinical symptoms - drowsiness in particular - and sleep breathing disorders, objectified by measuring the apnea-hypopnea index (AHI).
- Trial name
- OLIGO-SAS (NCT05758324)
- Testing
- Nutri PNEA
- Where
- France
- Volunteers
- 42 people
- Sponsor
- Laboratoires Pronutri
Restless Legs Syndrome
A Study To Investigate The Effects Of End Stage Renal Disease And Hemodialysis On The Pharmacokinetics Of Ropinirole
This study will investigate the effects of severe renal impairment and hemodialysis on the characteristics of the drug, ropinirole.
- Trial name
- NCT00422994
- Testing
- ropinirole dosing for up to 28 days
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Failure, Neuromuscular Disease
Ventilator Monitoring in Early Exacerbation Detection
The aim of this study is to determine whether respiratory disease exacerbations (a sudden worsening of symptoms) can be predicted by variables that are monitored by non-invasive ventilators (small machines that assist breathing)…
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease
- Trial name
- NCT01644162
- Testing
- iVAPS ventilation
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- ResMed
Restless Legs Syndrome (RLS)
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in…
- Trial name
- NCT03053427
- Testing
- Gabapentin enacarbil
- Where
- 46 sites in Japan
- Volunteers
- 375 people
- Sponsor
- Astellas Pharma Inc
Epilepsy, Partial
To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures
This will be a multi-center, randomized, double-blind, placebo-controlled, crossover study to evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well controlled partial onset seizures (on an…
- Trial name
- NCT02220972
- Testing
- Perampanel
- Sponsor
- Eisai Inc.
Obstructive Sleep Apnea
Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment.
- Trial name
- NCT02971436
- Testing
- FPH Device with SensAwake On + Pressure Support A, FPH Device with SensAwake Off + Pressure Support A, FPH Device with SensAwake On + Pressure Support B
- Where
- 2 sites in New Zealand
- Volunteers
- 29 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
eXciteOSA for Treatment of Mild Obstructive Sleep Apnea
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with mild OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA versus…
- Trial name
- OREM (NCT05183009)
- Testing
- eXciteOSA
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Signifier Medical Technologies
Narcolepsy Type 1
A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning.
- Trial name
- NCT07633301
- Testing
- TAK-360
- Where
- 18 sites in United States, Australia and 5 more
- Volunteers
- 92 people
- Sponsor
- Takeda
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