Clinical trials: Sleep Disorders, Intrinsic
Narcolepsy
Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy.
- Trial name
- NCT00066170
- Testing
- Xyrem, Modafinil at established dose
- Where
- 40 sites in United States, France and 2 more
- Volunteers
- 231 people
- Sponsor
- Jazz Pharmaceuticals
Insomnia Disorder
Safety and Efficacy Study of YZJ-1139 in Primary Chronic Insomnia Disorder
The main purpose of this study is to evaluate the efficacy and safety of YZJ-1139 in the short-term treatment of primary chronic insomnia, explore the optimal effective dose, and provide the basis for phase III clinical trials
- Trial name
- NCT06680505
- Testing
- YZJ-1139 10mg, YZJ-1139 20mg, YZJ-1139 40mg
- Where
- 33 sites in China
- Volunteers
- 300 people
- Sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Narcolepsy
Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy
The study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study CTP2S13031H3 (NCT04072380), and in instances when the investigator as well…
- Trial name
- NCT05530447
- Testing
- Samelisant
- Sponsor
- Suven Life Sciences Limited
Obstructive Sleep Apnea, Obesity
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP)…
- Trial name
- SURMOUNT-OSA (NCT05412004)
- Testing
- Tirzepatide
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 469 people
- Sponsor
- Eli Lilly and Company
Insomnia, Insomnia Chronic
Deep Sleep in Older Adults
This double blind randomized clinical trial on older independent-living healthy individuals with symptoms of insomnia will harness Cognitive Behavioral Therapy for Insomnia (CBT-I) and augment it with ambulatory data collection…
- Trial name
- NCT07316153
- Testing
- SleepSpaceRx CBT-I-IoT-AI, SleepEZ CBTi, Sleep Hygiene IoT
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Proactive Life Inc
Pediatric Obstructive Sleep Apnea, Down Syndrome (DS)
Pediatric Down Syndrome Post-Approval Study
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea.
- Trial name
- NCT06851338
- Testing
- Hypoglossal Nerve Stimulation
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Inspire Medical Systems, Inc.
Sleep Disordered Breathing
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
This pilot study is intended to evaluate the acceptance and performance of the DreamMapper application and the Therapist Assist educational tool in naïve patients with Obstructive Sleep Apnea who have been prescribed Positive…
- Trial name
- NCT03748264
- Testing
- Standard of Care, DreamMapper Application, DreamMapper Application with Therapist Assist
- Where
- 5 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Sleep Initiation and Maintenance Disorders
A Study With GW597599 And GR205171: Potential New Drugs For The Treatment Of Primary Insomnia
Patients with Primary Insomnia will be treated with GW597599 and GR205171 to evaluate the efficacy in the sleep difficulties associated with insomnia
- Trial name
- NCT00606697
- Testing
- GR205171, GW597599
- Where
- 10 sites in Germany
- Volunteers
- 51 people
- Sponsor
- GlaxoSmithKline
Idiopathic Hypersomnia, Narcolepsy
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.
- Trial name
- NCT05875974
- Testing
- JZP258 (XYWAV)
- Where
- 32 sites in United States, Canada
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
Narcolepsy Type 1, Hypersomnia
Efficacy of the Dreem 3S Ambulatory Sleep Monitoring Device for the Evaluation of Narcolepsy
This study intends to examine the utility of a home-use EEG-based sleep monitor for the diagnosis and evaluation of disorders of excessive sleepiness, specifically the neurological disorder Narcolepsy Type 1.
- Conditions
- Narcolepsy Type 1, Hypersomnia, Sleep Disorder
- Trial name
- NCT06531876
- Testing
- Dreem 3S recording
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Beacon Biosignals
Chronic Insomnia
Study of Efficacy of Ramelteon in Adults With Chronic Insomnia
The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of sleep
- Trial name
- NCT00671125
- Testing
- Ramelteon
- Where
- 25 sites in United States
- Volunteers
- 405 people
- Sponsor
- Takeda
Implementation; Digital Health, Chronic Insomnia
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
The purpose of this study is to compare three different ways to deploy a clinician-decision support platform called NOCTEM COAST among behavioral health care providers who encounter patients with insomnia.
- Trial name
- NCT04366284
- Testing
- No Facilitation Support, External Facilitation Support, External and Internal Facilitation Support
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Noctem, LLC
Restless Legs Syndrome
A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
The purpose of this study is to demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and…
- Trial name
- NCT03728933
- Testing
- Rotigotine 1 milligram/24 hours, Rotigotine 2 milligram/24 hours
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- UCB Biopharma SRL
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of Eschscholtzia Californica in Treating Primary Insomnia
The aim of this trial was to assess the efficacy and safety of Eschscholtzia Californica (EC) in treating patients having psycho-physiologic insomnia in a double-blind randomised placebo controlled trial during a 28-day treatment…
- Trial name
- NCT02183233
- Testing
- Eschscholtzia Californica
- Volunteers
- 49 people
- Sponsor
- Boehringer Ingelheim
Obstructive Sleep Apnea
Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)
The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst.
- Trial name
- NCT01010438
- Where
- 3 sites in Israel
- Volunteers
- 59 people
- Sponsor
- Oridion
Sleep Apnea
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
- Trial name
- NCT00906958
- Testing
- Nexus Flow Generator, VPAP Flow Generator 25
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Insomnia
Smart Devices-based Longitudinal Assessment of Patterns of Insomnia
The objective of the study is to develop an algorithm to detect insomnia and classify its severity, based on data collected during the use of Withings products and from questionnaires sent to users
- Trial name
- SLEEPI (NCT07430878)
- Testing
- Use of the Withings sleep-related devices, Questionnaires
- Where
- France
- Volunteers
- 17,000 people, healthy volunteers welcome
- Sponsor
- Withings
Insomnia, Sleep Initiation and Maintenance Disorders
Sleep Efficacy Randomized Evaluation of a Novel Digital Therapeutic for Insomnia
This study is a multicenter, randomized, double-blind, sham-controlled clinical investigation designed to evaluate the effectiveness and safety of BELL-001, a digital therapeutic developed to improve symptoms of insomnia.
- Trial name
- SERENE (NCT07295431)
- Testing
- BELL-001 Digital Therapeutic
- Where
- 6 sites in South Korea
- Volunteers
- 116 people
- Sponsor
- BELL Therapeutics Inc.
Transient Insomnia
SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.
The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty…
- Trial name
- NCT03331042
- Testing
- SM-1, D+Z, D+L
- Where
- 2 sites in United States
- Volunteers
- 85 people
- Sponsor
- Sequential Medicine Ltd
Insomnia
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel…
- Trial name
- NCT00525941
- Testing
- NBI-34060
- Where
- 4 sites in United States
- Sponsor
- Neurocrine Biosciences
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