Clinical trials: Excessive Daytime Somnolence, active
Idiopathic Hypersomnia
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).
- Trial name
- NCT07500090
- Testing
- HBS-301 tablet
- Where
- 42 sites in United States, Canada
- Volunteers
- 248 people
- Sponsor
- Harmony Biosciences Management, 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.
Sleep, Circadian Rhythm
Morning Bright Light Therapy and Daytime Functioning in University Students
This study tests whether a week of morning bright light therapy changes how well healthy young adults sleep and how alert, positive, and mentally sharp they feel during the day.
- Conditions
- Sleep, Circadian Rhythm, Daytime Sleepiness, Mood
- Trial name
- BLIGHT (NCT07685262)
- Testing
- Bright light therapy (10,000 lux light box)
- Where
- Hong Kong
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- The Hong Kong Polytechnic University
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.
Mental Health Issue, Insomnia
Promoting Teenage Sleep for Improved Mental Health and School Performance
The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent sleep and prevent future depressive symptoms.
- Conditions
- Mental Health Issue, Insomnia, Depression, Anxiety
- Trial name
- TeenSleep (NCT06306092)
- Testing
- Sleep on Schedule, Technology restriction
- Where
- Sweden
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Kristianstad University
Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
CLARITY (Clinical Assessment of Response in the Treatment of Depression with Daytime Sleepiness Using Solriamfetol) is a Phase 3, double-blind, placebo-controlled, multicenter randomized withdrawal trial in patients with major…
- Trial name
- CLARITY (NCT07484217)
- Testing
- Solriamfetol 150 MG
- Where
- 40 sites in United States
- Volunteers
- 508 people
- Sponsor
- Axsome Therapeutics, Inc.
Narcolepsy Type 1, Narcolepsy Type 2
A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2)…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT07096674
- Testing
- ORX750
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 90 people
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Narcolepsy Type 1
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- NCT07540897
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 20 sites in United States, Belgium and 3 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Obstructive Sleep Apnoea (OSA)
A Study Assessing Adult Patients Referred to an NHS Sleep Service With Suspected Obstructive Sleep Apnoea. This Study Aims to Compare the Sunrise Wearable Diagnostic Device Performance and Potential Inclusion in a NHS Diagnostic Pathway With Oximetry and WatchPAT Which Are Currently Used.
The goal of this clinical trial is to evaluate whether the Sunrise device (that measure small jaw movements) can improve the diagnosis and management of Obstructive Sleep Apnoea (OSA) in adults (≥ 18 years) referred to a Sleep…
- Trial name
- SOSA (NCT07269483)
- Testing
- WatchPAT 300, Oximetry, Sunrise
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Virginia Hawkins
Narcolepsy Type 1
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- Brilliance NT1 (NCT07455383)
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 150 people
- Sponsor
- Alkermes, Inc.
Narcolepsy Type 1, Narcolepsy Type 2
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS…
- Conditions
- Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
- Trial name
- NCT06767683
- Testing
- ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 786 people
- Sponsor
- Alkermes, Inc.
Prader-Willi Syndrome, Excessive Daytime Sleepiness
Impact of Bright Light Therapy on Prader-Willi Syndrome
This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome
- Conditions
- Prader-Willi Syndrome, Excessive Daytime Sleepiness, Hyperphagia, Body Weight
- Trial name
- PWS-LT (NCT05939453)
- Testing
- Bright Light Therapy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Maimonides Medical Center
Stroke, Sleep Apnea Syndrome (OSAS)
Sleep and Stroke Rehabilitation Study
The study aims to map sleep disorders and their impact on the ability to engage in an active daily life among people who have had a stroke, with particular focus on how sleep apnea can be identified.
- Conditions
- Stroke, Sleep Apnea Syndrome (OSAS), Insomnia, Excessive Daytime Sleepiness
- Trial name
- SnSRehabS (NCT07579871)
- Where
- Sweden
- Volunteers
- 226 people
- Sponsor
- Malin Eleonora av Kák Gustafsson, MD, PhD
Lumbar Disc Herniation, Obstructive Sleep Apnea Risk Management
Daytime vs Evening Rehabilitation in Lumbar Disc Herniation Patients at High Risk for Obstructive Sleep Apnea
Lumbar disc herniation is a common musculoskeletal condition that negatively affects quality of life, physical function, and daily activities.
- Trial name
- REHAB-TIME (NCT07522021)
- Testing
- Physiotherapy and Exercise Program
- Volunteers
- 60 people
- Sponsor
- Mardin Artuklu University
Multiple Sclerosis, Multiple Sclerosis Fatigue
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
Fatigue is a prevalent and disabling symptom in Multiple Sclerosis (MS), affecting up to 90% of patients. Current treatments, including off-label prescriptions of wake-promoting agents, have shown limited effectiveness.
- Trial name
- SOLARIMS (NCT06170970)
- Testing
- Solriamfetol
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Johns Hopkins University
Excessive Daytime Sleepiness, Obstructive Sleep Apnea (OSA)
Validating a Novel Driving Simulation-based MWT Against the Standard MWT in an OSA-cohort Challenged by CPAP-withdrawal
In brief, the proposed study will evaluate a recently proposed naturalistic, driving simulation test to identify and measure sleepiness behind the wheel, one of the most underestimated causes of road accidents.
- Conditions
- Excessive Daytime Sleepiness, Obstructive Sleep Apnea (OSA), CPAP Treatment, Driving Simulator Performance
- Trial name
- DS-MWT2 (NCT06872593)
- Testing
- CPAP-withdrawal, Test Sequence
- Where
- Switzerland
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Stefan Lakämper
Parkinson's Disease
Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease
Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain…
- Trial name
- NCT02909192
- Testing
- Light Therapy Device
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Massachusetts General Hospital
Narcolepsy Type 2
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.
- Trial name
- Brilliance NT2 (NCT07502443)
- Testing
- ALKS 2680 Dose 1, ALKS 2680 Dose 2, ALKS 2680 Dose 3
- Where
- 44 sites in United States, Australia and 8 more
- Volunteers
- 176 people
- Sponsor
- Alkermes, Inc.
Insomnia
Digital Sleep Program for College Students with Insomnia
This randomized controlled trial (RCT) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia…
- Trial name
- DSP-CS (NCT06853106)
- Testing
- Waitlist control group, digital-based multimodal sleep management program
- Where
- Taiwan
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Taipei Medical University
Idiopathic Hypersomnia
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
- Trial name
- Vibrance-3 (NCT06843590)
- Testing
- ALKS 2680
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 126 people
- Sponsor
- Alkermes, Inc.