Clinical trials: Sleep Disorders, Intrinsic
Excessive Daytime Sleepiness
A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age
Characterize the safety, tolerability and pharmacokinetics of ORX142 following single and multiple doses.
- Trial name
- NCT07082829
- Testing
- ORX142 Tablets
- Where
- 3 sites in United States
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Sleep Apnea, Obstructive
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification.
- Trial name
- NCT00681083
- Testing
- Heated breathing tube (CPAP with ThermoSmart), Non heated breathing tube (CPAP with conventional humidification)
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Fisher and Paykel Healthcare
Restless Legs Syndrome (RLS)
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in…
- Trial name
- NCT03053427
- Testing
- Gabapentin enacarbil
- Where
- 46 sites in Japan
- Volunteers
- 375 people
- Sponsor
- Astellas Pharma Inc
Sleep, Insomnia
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation.
- Conditions
- Sleep, Insomnia, Sleep Apnea Syndrome, Obstructive
- Trial name
- NCT04943562
- Testing
- ACT+EEG
- Where
- 2 sites in Brazil
- Volunteers
- 96 people
- Sponsor
- SleepUp Tecnologia em Saúde Ltda
Quality of Life, Obesity
Effect of Consumption of Pep19 on Quality of Life
Pep19 is a naturally occurring peptide (protein) that triggers loss of body fat. It has been certified Generally Recognized as Safe (GRAS) at up to 3.8 grams per day and may be included in various foods.
- Conditions
- Quality of Life, Obesity, Sleep Quality
- Trial name
- NCT06359327
- Testing
- Pep19 2 mg, Pep19 5 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Proteimax Biotechnology Israel LTD
Obstructive Sleep Apnea
A Comparison of CPAP With and Without Humidification: A Pilot Study
To compare a group of patients with our standard treatment of continuous positive airway pressure (CPAP) and another group of patients with CPAP and a humidifier attached.
- Trial name
- NCT02423681
- Testing
- ThermoSmart, Without ThermoSmart
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Insomnia, Sleep
Frequen-ZZZ SleepPad Investigational Device POC
The investigators propose to examine the potential effects of the Frequen- ZZZ sleep pad - a noninvasive, unobtrusive appliance that generates a localized low-level electromagnetic field via radiofrequency, and that is used on…
- Conditions
- Insomnia, Sleep, Sleep Disturbance
- Trial name
- NCT05908344
- Testing
- Activated Sleep Pad system (Frequen-ZZZ), Deactivated Sleep Pad system (Frequen-ZZZ)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Kunasan Inc.
Narcolepsy
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE)
The primary objective of this study is to evaluate the effect of Samelisant on excessive daytime sleepiness (EDS) after 12 weeks of treatment.
- Trial name
- NCT07540364
- Testing
- Samelisant
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Suven Life Sciences Limited
Obstructive Sleep Apnea
AD109 Dose Finding in Mild to Moderate OSA
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.
- Trial name
- NCT04631107
- Testing
- AD109 dose1- A, AD109 dose2- B
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- Apnimed
Sleep Apnea, Obstructive
Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the…
- Trial name
- NCT00750165
- Testing
- SleepStyle 200 Auto Series CPAP Humidifier
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Insomnia Disorder
Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.
- Trial name
- NCT02350309
- Testing
- Lemborexant 5 mg, Lemborexant 10 mg, Flurazepam 30 mg
- Where
- 2 sites in United States
- Volunteers
- 69 people
- Sponsor
- Eisai Inc.
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
Obstructive Sleep Apnea
Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
The investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
- Trial name
- NCT03329352
- Testing
- F&P Full-Face Mask
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Fisher and Paykel Healthcare
Excessive Sleepiness
Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance
The primary objective of this study is to determine whether treatment with armodafinil will provide improvements in prefrontal cortical activation in patients with OSAHS (Obstructive Sleep Apnea/Hypopnea Syndrome) who have…
- Trial name
- NCT00711516
- Testing
- Armodafinil
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Cephalon
Primary Insomnia
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.
- Trial name
- NCT01896336
- Testing
- Zolpidem Hemitartrate
- Where
- Brazil
- Volunteers
- 67 people
- Sponsor
- EMS
Obstructive Sleep Apnea (OSA)
Evaluate the Efficacy and Safety of GZR18 Injection in Obese Subjects With Obstructive Sleep Apnea Receiving Positive Airway Pressure (PAP) Therapy
The study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of GZR18 injection in Chinese adult obese patients with moderate-to-severe…
- Trial name
- NCT07501832
- Testing
- GZR18 injection
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Narcolepsy Type 1 (NT1)
A Study to Evaluate the Efficacy, Safety, and Tolerability of E2086 Compared to Placebo and Active Comparator in Adult Participants With Narcolepsy Type 1
The primary purpose of this study is to evaluate the efficacy of single oral doses of E2086 compared to placebo in the treatment of excessive daytime sleepiness (EDS) as assessed by the Maintenance of Wakefulness Test (MWT) in…
- Trial name
- NCT06462404
- Testing
- E2086, Active Comparator
- Where
- 14 sites in United States, Canada
- Volunteers
- 22 people
- Sponsor
- Eisai Inc.
Insomnia Disorder
Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder
The main study objective is to assess the content validity and the psychometric characteristics of the Insomnia Daytime Symptoms and Impacts Questionnaire™ (IDSIQ™).
- Trial name
- NCT03056053
- Testing
- Zolpidem
- Where
- 9 sites in United States, Germany
- Volunteers
- 113 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Obstructive Sleep Apnea
An Investigation to Test the Efficacy of the High Flow (HF) Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea (OSA)
Phase One: High Flow (HF) CPAP (HF-CPAP) Titration: Participants will attend the sleep lab to undergo a comprehensive split-night respiratory PSG.
- Trial name
- NCT01025440
- Testing
- Continuous Positive Airway Pressure
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea (OSA)
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
- Trial name
- AHIBMI PAS (NCT07113288)
- Testing
- Inspire® UAS System
- Where
- 5 sites in United States
- Volunteers
- 70 people
- Sponsor
- Inspire Medical Systems, Inc.