Clinical trials: Sleep Disorders, Intrinsic
Central Sleep Apnea
Post Approval Study of the remedē System
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
- Trial name
- NCT03425188
- Where
- 17 sites in United States, Germany
- Volunteers
- 53 people
- Sponsor
- Respicardia, Inc.
Prader-Willi Syndrome
A Study of Pitolisant in Patients With Prader-Willi Syndrome
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.
- Trial name
- NCT06366464
- Testing
- Pitolisant tablet
- Where
- 57 sites in United States, Australia and 11 more
- Volunteers
- 134 people
- Sponsor
- Harmony Biosciences Management, Inc.
Apnea, Sleep
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in…
- Trial name
- NCT02349893
- Testing
- RFA treatment
- Where
- 6 sites in United States
- Volunteers
- 56 people
- Sponsor
- Olympus Surgical Technologies Europe
Obstructive Sleep Apnea
US Clinical Study of the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea
The overall goal of the study is to evaluate the safety, efficacy and therapy settings of the Hypoglossal Nerve Stimulation (HGNS) System for stimulating the hypoglossal nerve to help maintain airway opening in subjects with…
- Trial name
- NCT01211444
- Testing
- HGNS Treatment
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Apnex Medical, Inc.
Obstructive Sleep Apnea
TheraPAP Equivalence Crossover Study
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
- Trial name
- NCT06238362
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- SleepRes Inc.
Obstructive Sleep Apnea
PAP Systems Internal Clinical Studies (ICS)
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems to guide product development.
- Trial name
- NCT06173050
- Testing
- PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi)
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed
Sleep Disordered Breathing, Cheyne Stokes Respiration
Chronic Evaluation of Respicardia Therapy
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA).
- Conditions
- Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea
- Trial name
- NCT01124370
- Testing
- remedē (TM) system
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 57 people
- Sponsor
- Respicardia, Inc.
Narcolepsy
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Primary Objectives: The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive sleepiness (ES) associated with…
- Trial name
- NCT00107796
- Testing
- Modafinil
- Where
- 73 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Sleep Initiation and Maintenance Disorders
Disturbed Sleep Model Study.
Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.
- Trial name
- NCT00440323
- Testing
- SB-649868, Zolpidem
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Insomnia
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device vs. sham device in adult patients with chronic Insomnia
- Trial name
- NCT02236845
- Where
- Israel
- Volunteers
- 40 people
- Sponsor
- Lacrima Medical LTD
Chronic Respiratory Conditions, Obstructive Sleep Apnea (OSA)
Evaluation of F&P Mask, US, 2026
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P mask in a home environment.
- Trial name
- NCT07847814
- Testing
- F&P Mask
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Major Depressive Disorder (MDD)
A Study to Evaluate the Safety and Efficacy of ALKS 7290 as an Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder
The purpose of this study is to assess the efficacy, safety and tolerability of ALKS 7290 following oral administration in adult participants with Major Depressive Disorder.
- Trial name
- NCT07901179
- Testing
- ALKS 7290 Dose
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Alkermes, Inc.
Primary Insomnia
A Study of Gaboxadol in Primary Insomnia
To evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia.
- Trial name
- NCT00209924
- Testing
- Gaboxadol
- Where
- Sweden
- Volunteers
- 505 people
- Sponsor
- H. Lundbeck A/S
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.
Narcolepsy, Obstructive Sleep Apnea
SUNOSI® (Solriamfetol) Pregnancy Registry
The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep…
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
- Trial name
- NCT06413420
- Testing
- Sunosi (solriamfetol), Other prescription wake-promoting medications or stimulants, No treatment
- Where
- 2 sites in United States
- Volunteers
- 1,731 people
- Sponsor
- Axsome Therapeutics, Inc.
Obstructive Sleep Apnea Syndrome
Safety and Efficacy of Eszopiclone With Mild to Moderate Obstructive Sleep Apnea Syndrome (OSAS)
The purpose of this study is to evaluate the hypnotic efficacy of ezopiclone in subjects with mild to moderate OSAS.
- Trial name
- NCT00685269
- Testing
- Eszopiclone
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sumitomo Pharma America, Inc.
Sleep Apnea, Obstructive, Hypopnea Syndrome
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous…
- Conditions
- Sleep Apnea, Obstructive, Hypopnea Syndrome, Excessive Daytime Sleepiness
- Trial name
- NCT00620659
- Testing
- Comparator: MK0249, Comparator: modafinil
- Volunteers
- 125 people
- Sponsor
- Merck Sharp & Dohme LLC
Narcolepsy Type 1, Narcolepsy With Cataplexy
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1
The goal of this clinical trial is to see how NLS-2 (mazindol extended-release) works on symptoms of narcolepsy, including cataplexy and excessive daytime sleepiness.
- Trial name
- AMAZE (NCT05914194)
- Testing
- NLS-2
- Volunteers
- 48 people
- Sponsor
- NLS Pharmaceutics
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.
Obstructive Sleep Apnea
Safety and Performance Study of the Nyxoah SAT System for Treating OSA
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
- Trial name
- NCT02312479
- Testing
- Nyxoah SAT system
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- Nyxoah S.A.
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