Clinical trials: Sleep Disorders, Intrinsic
Restless Legs Syndrome (RLS)
Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS
This will be a Phase III, double blinded, multi-center, randomized, placebo-controlled study. Eligible subjects will be randomized in a 1:1 ratio to receive Injectafer or Placebo on days 0 and 5.
- Trial name
- NCT02397057
- Testing
- Injectafer
- Where
- 19 sites in United States
- Volunteers
- 209 people
- Sponsor
- American Regent, Inc.
Insomnia
A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of Insomnia
The primary objective of the study is to evaluate the proportion of adult [greater than or equal to (>=) 18 years] participants with insomnia disorder taking zolpidem tartrate immediate release (ZOL-IR) or zolpidem tartrate…
- Trial name
- NCT04009577
- Testing
- LEM 5 mg, LEM 10 mg
- Where
- 17 sites in United States
- Volunteers
- 53 people
- Sponsor
- Eisai Inc.
Sleep Disordered Breathing, Congestive Heart Failure
Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.
- Trial name
- NCT02152566
- Testing
- Nasal High flow therapy device
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Fisher and Paykel Healthcare
Chronic Heart Failure, Central Sleep Apnea
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)
The purpose of FACE study is to provide in routine practice complementary long-term data on the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea eligible for Adaptative Servo-Ventilation…
- Trial name
- FACE (NCT01831128)
- Testing
- ASV Treatment
- Where
- 18 sites in France
- Volunteers
- 509 people
- Sponsor
- ResMed
Metabolic Syndrome, Obesity Hypoventilation Syndrome
Obesity-hypoventilation in Metabolic Syndrom Patients
The purpose of the study is to determined the prevalence of obesity-hypoventilation syndrome in patients with metabolic syndrom.
- Conditions
- Metabolic Syndrome, Obesity Hypoventilation Syndrome, Capnography
- Trial name
- NCT04839419
- Where
- France
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- SOS Oxygene Mediterranee
Restless Legs Syndrome
Response to an Investigational Device in Patients With Restless Legs Syndrome
This study assesses the tolerability, safety, and impact of an investigational medical device on restless legs syndrome symptoms. The IRB has established that the investigational device is non-significant risk.
- Trial name
- NCT06866132
- Testing
- Investigational Noninvasive Neuromodulation Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Noctrix Health, Inc.
Insomnia, Sleep Initiation and Maintenance Disorders
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants with chronic primary insomnia.
- Conditions
- Insomnia, Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias
- Trial name
- NCT00561821
- Testing
- Esmirtazapine
- Volunteers
- 538 people
- Sponsor
- Merck Sharp & Dohme LLC
Insomnia
Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause
To demonstrate improved subjective sleep in women with insomnia secondary to perimenopause or menopause following treatment with 3 mg of eszopiclone.
- Trial name
- NCT00366093
- Testing
- Eszopiclone
- Where
- 51 sites in United States
- Volunteers
- 410 people
- Sponsor
- Sumitomo Pharma America, Inc.
Insomnia
Zolpidem Postmarketing Study in Adolescent Patients With Insomnia
To investigate the efficacy and safety of zolpidem for pediatric insomniacs in a randomized double blind-controlled trial
- Trial name
- NCT00432198
- Testing
- Zolpidem (Myslee®)
- Where
- 7 sites in Japan
- Volunteers
- 122 people
- Sponsor
- Astellas Pharma Inc
Obstructive Sleep Apnea (OSA)
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance.
- Trial name
- NCT02214238
- Testing
- PAP device
- Where
- New Zealand
- Volunteers
- 49 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348606)
- Testing
- JZP-110
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 476 people
- Sponsor
- Jazz Pharmaceuticals
Sleep Initiation and Maintenance Disorders
Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia
Given the potential age-related differences in safety, tolerability, pharmacokinetics, and differences in sleep architecture in young children versus adolescent versus adult, studies to identify the appropriate drug and dosage…
- Trial name
- PKiDs (NCT00913614)
- Testing
- Eplivanserin (SR46349)
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Sanofi
Narcolepsy, Excessive Daytime Sleepiness
A Phase 1, Single Dose Study of JZP-386 to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
This study is being conducted to evaluate the safety, tolerability, blood distribution and effectiveness single ascending doses of JZP-386 compared to doses of Xyrem® and placebo.
- Trial name
- NCT02215499
- Testing
- Sodium Oxybate, JZP-386
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Concert Pharmaceuticals
Narcolepsy
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.
- Trial name
- NCT01681121
- Testing
- ADX-N05
- Where
- 28 sites in United States
- Volunteers
- 93 people
- Sponsor
- Jazz Pharmaceuticals
ADHD, Narcolepsy
Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)
This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a manipulated commercially-available d-amphetamine…
- Trial name
- NCT04232644
- Testing
- ADAIR 10mg IR capsules, Crushed d-amphetamine sulfate IR tablets
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vallon Pharmaceuticals, Inc.
Blood Oxygen Desaturations, Sleep-Disordered Breathing
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep.
- Trial name
- WAGSC1 (NCT04886583)
- Testing
- Gabi Baby Band
- Where
- 3 sites in Belgium
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Narcolepsy, Cataplexy
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).
- Conditions
- Narcolepsy, Cataplexy, Excessive Daytime Sleepiness
- Trial name
- NCT05113745
- Testing
- AXS-12 (reboxetine)
- Where
- 25 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Axsome Therapeutics, Inc.
Obstructive Sleep Apnea, Sleep Apnea
Continuation Protocol for Study Using Negative Pressure to Reduce Apnea Trial
The goal of this study is to allow continued access to the aerSleep II System for subjects that have completed the SOM-029 study until the device is commercially available.
- Trial name
- CO-STAR (NCT05608486)
- Testing
- aerSleep II
- Sponsor
- Sommetrics, Inc.
Obstructive Sleep Apnea
Developement of TipTraQ Home Sleep Test
The clinical study aims to develop and fine-tune the TipTraQ system, created by PranaQ, for home sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and…
- Trial name
- NCT06474351
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Restless Legs Syndrome
Benefits of a Cannabidiolic Acid Topical Cream for the Treatment of Restless Leg Syndrome
The goal of this open label clinical trial is to reduce the effects of restless leg syndrome. The main it questions it aims to answer are: 1. Reduce or eliminate the symptoms of restless leg syndrome. 2.
- Trial name
- NCT06570941
- Testing
- Chylobinoid Topical Cream
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Synthonics Inc
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