Clinical trials: Sleep Disorders
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.
Sleep Apnea, Obstructive, Chronic Obstructive Pulmonary Disease
SNORE (Smartphone Analyses of Nocturnal Obstruction by Respiratory Evaluation) SOUNDS
This is a prospective multipart clinical performance study to compare the ability of the SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST) device to identify patients with obstructive sleep…
- Trial name
- SNORESOUNDS (NCT03288376)
- Where
- 3 sites in United States
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Incyphae, 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.
Healthy Participants, Narcolepsy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
- Trial name
- NCT03748979
- Testing
- TAK-925
- Where
- 3 sites in Japan
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Takeda
Insomnia Disorder
Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder.
Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women…
- Trial name
- ZOLP_18_01 (NCT03885141)
- Testing
- Zolpidem
- Volunteers
- 366 people
- Sponsor
- Biolab Sanus Farmaceutica
Insomnia, Insomnia Chronic
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before…
- Conditions
- Insomnia, Insomnia Chronic, Sleep
- Trial name
- NCT04627480
- Testing
- Fisher Wallace Neurostimulation Device
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- ProofPilot
Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
The purpose of study JZP110-405 is to determine whether solriamfetol is effective at improving cognitive function in participants with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) plus impaired…
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function
- Trial name
- SHARP (NCT04789174)
- Testing
- Solriamfetol
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 59 people
- Sponsor
- Axsome Therapeutics, Inc.
Excessive Sleepiness, Shift Work Sleep Disorder
Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder…
- Trial name
- NCT00080288
- Testing
- Armodafinil 150 mg/day
- Volunteers
- 254 people
- Sponsor
- Cephalon
Restless Legs Syndrome
Alpha-lipoic Acid Combined With B Vitamins Shows Promise for Treating Restless Legs Syndrome
Investigating Tiobec® 400's efficacy in alleviating Restless Legs Syndrome symptoms sheds light on promising therapeutic avenues.
- Trial name
- NCT06324760
- Testing
- Alpha-lipoic acid combined with B vitamins
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Uriach Consumer Healthcare
Sleep Apnea
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population
- Trial name
- NCT03120897
- Testing
- RAM sensor
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Masimo Corporation
Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm
Evaluating the Effects of Tasimelteon vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD)
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.
- Conditions
- Sleep Wake Disorders, Sleep Disorders, Circadian Rhythm, Chronobiology Disorders
- Trial name
- NCT04652882
- Testing
- Tasimelteon
- Where
- 17 sites in United States, Austria and 1 more
- Volunteers
- 43 people
- Sponsor
- Vanda Pharmaceuticals
Sleep Apnea, Obstructive
New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults
Obstructive sleep apnea (OSA) is a condition of disordered breathing characterised by intermittent partial and/or complete upper airway obstruction during sleep.
- Trial name
- APAP (NCT01210261)
- Testing
- Compumedics Somnilink SPAP - Auto-titrating CPAP, Resmed Autoset S8 - Auto-titrating CPAP
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Compumedics Limited
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
Obstructive Sleep Apnea
RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway…
- Trial name
- REPOSA (NCT06146101)
- Testing
- IHL-42X Low Dose, IHL-42X High Dose, IHL-42X (Optimal Dose)
- Where
- 20 sites in United States
- Volunteers
- 121 people
- Sponsor
- Incannex Healthcare Ltd
Sleep Problems
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin…
- Trial name
- NCT01903681
- Testing
- Circadin 2 mg, Circadin 10 mg
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- Neurim Pharmaceuticals Ltd.
Obstructive Sleep Apnea
Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.
- Trial name
- NCT01799265
- Testing
- Somnetics Transcend Auto, Respironics REMstar Auto with C-Flex
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- Somnetics International, Inc.
Obesity
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.
- Trial name
- NCT00603902
- Testing
- Lorcaserin 10 mg once daily (QD), Lorcaserin 10 mg twice a day (BID)
- Where
- United States
- Volunteers
- 4,008 people
- Sponsor
- Eisai Inc.
Sleep Apnea, Sleep-Disordered Breathing
Alice PDx User/Validation Extended Trial
The objective of this study is to test the usability of the Alice PDx device by both the end user (patient/participant) and the sleep technician.
- Trial name
- NCT00841906
- Testing
- Alice PDx with only written instructions, Alice PDx with written and verbal instructions
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Philips Respironics
Sleep, Sleep Disturbance
Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time
This study seeks to test whether auditory stimulation delivered at specific phases of the alpha oscillation (as measured by electroencephalogram) can accelerate sleep onset.
- Trial name
- SLEEPFAST (NCT05743114)
- Testing
- Elemind Neuromodulation (ENMod)
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Elemind Technologies, Inc.
Cancer-related Problem/Condition, Fatigue in Cancer Survivors
Decentralized Clinical Trial of Effectiveness of EnergyPoints App in Cancer Survivors
The purpose of the study is to evaluate whether EnergyPoints, a mobile phone health app that guides the participant to do self-acupressure, can decrease fatigue and improve sleep.
- Conditions
- Cancer-related Problem/Condition, Fatigue in Cancer Survivors, Sleep Disturbances, Health-related Quality of Life
- Trial name
- NCT06754722
- Testing
- App to guide self-acupressure
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- 5 Point App, Inc.