Clinical trials: Sleep Disorders, Intrinsic
Obstructive Sleep Apnea
Pediatric Nasal Mask Usability Study
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
- Trial name
- NCT01154322
- Testing
- Pixi pediatric mask
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- ResMed
Sleep Initiation and Maintenance Disorders
Efficacy and Safety of KI1001 in the Treatment of ≥ 55 Years Old Insomnia Patients
KI1001(Circadin®, Prolonged release tablet which contains melatonin) has showed its efficacy to improve sleep quality in over 55 years old primary insomnia patients.
- Trial name
- NCT02087722
- Testing
- KI1001
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd.
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.
Insomnia, Major Depressive Disorder
The Exploratory Study to Investigate the Effect of Ramelteon for Insomnia Patients With Major Depressive Disorder by Using Actigraphy
The purpose of this study is to investigate exploratorily the effect of ramelteon 8 mg once daily for 8 weeks in the treatment of insomnia patients with depression by using actigraphy.
- Trial name
- NCT02669082
- Testing
- Ramelteon
- Where
- 7 sites in Japan
- Volunteers
- 26 people
- Sponsor
- Takeda
Acute Decompensated Heart Failure, Sleep Disordered Breathing
Cardiovascular Improvements With MV ASV Therapy in Heart Failure
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF.
- Trial name
- CAT-HF (NCT01953874)
- Testing
- MV ASV, Optimized Medical Treatment
- Where
- 15 sites in United States, Germany
- Volunteers
- 126 people
- Sponsor
- ResMed
Insomnia Disorder
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects With Insomnia Disorder
The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.
- Trial name
- NCT03545191
- Testing
- Daridorexant 25 mg, Daridorexant 50 mg
- Where
- 81 sites in United States, Australia and 8 more
- Volunteers
- 930 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Primary Insomnia
Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028)
This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time…
- Trial name
- NCT01097616
- Testing
- Suvorexant High Dose (HD), Suvorexant Low Dose (LD)
- Volunteers
- 1,023 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
The primary objective of the study is to evaluate the safety and tolerability of Neu-P11, following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching placebo) given nightly over 2 periods of 5 days…
- Trial name
- NCT01114126
- Testing
- Neu-P11
- Where
- France
- Volunteers
- 24 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Targeted Hypoglossal Neurostimulation Study #2
The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory
- Trial name
- THN2 (NCT01796925)
- Testing
- aura6000 THN System
- Where
- 9 sites in United States, Belgium and 3 more
- Volunteers
- 57 people
- Sponsor
- ImThera Medical, Inc.
Insomnia
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects
- Trial name
- NCT04596007
- Testing
- HEC83518 tablets
- Where
- China
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Obstructive Sleep Apnea
REV 002 Observational Study of the ReVENT Sleep Apnea System: Minimally Invasive Treatment for Obstructive Sleep Apnea
The purpose of this post-market observational study is to assess the effectiveness and patient perception of benefit of the ReVENT Sleep Apnea System in patients diagnosed with Obstructive Sleep Apnea due to primary tongue base…
- Trial name
- NCT02180815
- Testing
- ReVENT Sleep Apnea System
- Where
- 14 sites in Belgium, Czechia and 3 more
- Volunteers
- 50 people
- Sponsor
- Revent Medical International B.V.
Insomnia
Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia
The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.
- Trial name
- NCT03814135
- Testing
- Hipnos 3, Hipnos 5
- Sponsor
- EMS
Major Depressive Disorder Co-Occurrent With Anxiety, Adult Patients
First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic
According to the local guidelines (Recommendation for General Practitioners), the first choice Anti-Depressant (AD) in Major Depressive Disorder (MDD) in primary care should be selective serotonin reuptake inhibitors (SSRI), e.g.
- Conditions
- Major Depressive Disorder Co-Occurrent With Anxiety, Adult Patients, Newly Diagnosed Depression
- Trial name
- FIAT (NCT05291897)
- Where
- 6 sites in Czechia
- Volunteers
- 28 people
- Sponsor
- Angelini Pharma Česká republika s.r.o.
Restless Legs Syndrome
An Extension Trial to Investigate Long-Term Treatment With Transdermal Rotigotine in Idiopathic Restless Legs Syndrome
This is a multicenter, open-label trial to assess safety and tolerability of rotigotine (SPM 936) in subjects with idiopathic Restless Legs Syndrome (RLS), administered at an optimal dose for up to 1 year.
- Trial name
- NCT00263068
- Testing
- Rotigotine
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- UCB Pharma
Insomnia, Insomnia Chronic
Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.
- Trial name
- TINA (NCT07420816)
- Testing
- APSTZD 1, APSTZD 2, APSTZD 3
- Where
- Brazil
- Volunteers
- 222 people
- Sponsor
- Apsen Farmaceutica S.A.
Obstructive Sleep Apnea (OSA)
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA.
- Trial name
- NCT02639884
- Testing
- SedLine EEG, RRa monitoring
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Masimo Corporation
Insomnia Disorder
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
- Trial name
- NCT03679884
- Testing
- Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg
- Where
- 106 sites in United States, Belgium and 12 more
- Volunteers
- 804 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Sleep Apnea, Asthma
Sleepiz One+ vs. Capnography and Electrocardiography
Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors.
- Conditions
- Sleep Apnea, Asthma, COPD, Hypertension
- Trial name
- NCT06569940
- Testing
- Sleepiz One+
- Where
- Switzerland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Sleepiz AG
OSA
Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)
This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
- Trial name
- NCT05813275
- Testing
- AD109
- Where
- 73 sites in United States, Canada
- Volunteers
- 646 people
- Sponsor
- Apnimed
Sleep Apnea (Disorder)
Evaluation of a Disposable Sound Sensor for Recording Respiration During Sleep
Split-night prospective monocentric study to evaluate, in real conditions, the effectiveness of a disposable tracheal sound sensor.
- Trial name
- NCT05272449
- Testing
- Sleep apnea diagnosis
- Volunteers
- 20 people
- Sponsor
- CIDELEC