Clinical trials: Disorders of Excessive Somnolence
Narcolepsy
TElemedicine for NARcolepsy
The TENAR trial is the first randomized controlled trial (RCT) designed to evaluate the feasibility, efficacy, safety, and costs of a Telemedicine multidisciplinary approach for the management of narcolepsy.
- Trial name
- TENAR (NCT04316286)
- Testing
- Tele-multidisciplinary care, Standard care
- Where
- Italy
- Volunteers
- 202 people
- Sponsor
- Azienda Usl di Bologna
Obstructive Sleep Apnea of Adult, Insomnia
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study
Sustainable Methods, Algorithms, and Research Tools for Delivering Optimal Care Study (SMART DOCS) was designed to develop and evaluate a new approach (patient-centered outcomes and coordinated-care management [PCCM]) for the…
- Conditions
- Obstructive Sleep Apnea of Adult, Insomnia, Circadian Rhythm Sleep Disorder, Sleep Related Movement Disorders
- Trial name
- SMART DOCS (NCT02037438)
- Testing
- CONV care for the diagnosis and treatment of sleep disorders, PCCM for the diagnosis and treatment of sleep disorders
- Where
- United States
- Volunteers
- 1,836 people
- Sponsor
- Stanford University
Sleep Apnea, Obstructive, OSA
Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)
The goal of the study is to test the role of telemedicine combined with humidification to check CPAP treatment during the first month to improve adherence and reduce unsolved side effects of therapy.
- Conditions
- Sleep Apnea, Obstructive, OSA, Sleep, Sleep Disorder
- Trial name
- THINK (NCT04300166)
- Testing
- Telemedicine & Humidification
- Volunteers
- 100 people
- Sponsor
- Andrea Romigi
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 Initiation and Maintenance Disorders, Circadian Rhythm Sleep Disorders
Light Exposure to Treat Sleep Disruption in Older People
The purpose of this study is to test whether shifts in the timing of the biological clock to a later hour (phase delay shifts of the human circadian system) can be produced in response to four successive evenings of light…
- Conditions
- Sleep Initiation and Maintenance Disorders, Circadian Rhythm Sleep Disorders, Hypersomnia
- Trial name
- NCT00427323
- Testing
- light exposure
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Obstructive Sleep Apnea
Bright Light Therapy for Residual Daytime Symptoms Associated With Obstructive Sleep Apnea
Sleep apnea is one of the most common chronic condition among US military Veterans, causing sleepiness, reduced psychomotor vigilance and depression, which undermine daytime functioning and quality of life.
- Trial name
- NCT04299009
- Testing
- Bright light therapy glasses
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- VA Office of Research and Development
Rare Disorders, Undiagnosed Disorders
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research.
- Conditions
- Rare Disorders, Undiagnosed Disorders, Disorders of Unknown Prevalence, Cornelia De Lange Syndrome
- Trial name
- CoRDS (NCT01793168)
- Where
- United States
- Volunteers
- 20,000 people
- Sponsor
- Sanford Health
Idiopathic Hypersomnia
Low Sodium Oxybate in Patients With Idiopathic Hypersomnia
Low sodium oxybate has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic hypersomnia.
- Trial name
- NCT05837091
- Testing
- Low Sodium Oxybate, 24-hour polysomnography, Nextsense EEG earbuds
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mayo Clinic
Bipolar Disorder, Insomnia
Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS) meditation intervention for individuals with bipolar I disorder with insomnia (i.e. difficulties falling or staying asleep).
- Conditions
- Bipolar Disorder, Insomnia, Hypersomnia, Sleep Problems
- Trial name
- NCT01764035
- Testing
- Body Scan (BS) Meditation Intervention, Brief Supportive Psychotherapy (SP)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Massachusetts General Hospital
Narcolepsy 1, Idiopathic Hypersomnia
The Role of the Circadian System in Neurological Sleep-wake Disorders
The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap…
- Trial name
- PNP (NCT03356938)
- Testing
- Sleep restriction, Sleep deprivation
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Esther Werth
Sleep Deprivation, Depression
Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit
The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.
- Trial name
- NCT00996320
- Testing
- Reduced work hour schedule
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Providence Health & Services
Hypersomnia
Disentangling the Role of Depression in Hypersomnia
Individuals who have disorders of hypersomnolence (excessive sleepiness) often report symptoms of depression. The goal of this study is to further understand of the relationship between depression and hypersomnia by examining…
- Trial name
- NCT05850676
- Testing
- Sleep study
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- University of Pennsylvania
Sleep Apnea
A Combined Surgical and Medical Approach in Mild Sleep Apnea
The aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.
- Trial name
- NCT00497120
- Testing
- acetazolamide, uvulopalatopharygoplasty
- Where
- Belgium
- Sponsor
- University Hospital, Antwerp
Post-Acute COVID-19 Syndrome, ME/CFS
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related…
- Conditions
- Post-Acute COVID-19 Syndrome, ME/CFS, Rheumatic Arthritis, Juvenile Rheumatoid Arthritis (JRA)
- Trial name
- NCT04806620
- Where
- United States
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- Brain Inflammation Collaborative
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
Narcolepsy Type 1 (NT 1)
Extended-release Sodium Oxybate in Children
The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the…
- Trial name
- NCT06809803
- Testing
- Extended-release sodium oxybate, Non-extended-release oxybates
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Stanford University
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
Sleep Apnea, Obstructive
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
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 obstructive sleep…
- Trial name
- NCT00107809
- Testing
- Modafinil
- Where
- 64 sites in United States, Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Cephalon
Narcolepsy, Amyloid Pathology
Narcolepsy Protect Against Alzheimer's Disease?
Links between orexin and amyloid processes have been underlined recently. During the Alzheimer's process an upregulation of the orexin mechanism has been observed.
- Trial name
- PROTECMAN (NCT03378453)
- Testing
- PET-scan18F-AV-45
- Where
- France
- Volunteers
- 38 people
- Sponsor
- University Hospital, Montpellier
Excessive Daytime Sleepiness
Alternative Epworth Sleepiness Scale ESS-ALT in French
The Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.
- Trial name
- SOMNOLD (NCT05822128)
- Testing
- Test of an alternative Epworth Sleepiness Scale ESS-ALT in French
- Where
- 2 sites in France
- Volunteers
- 102 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris