Clinical trials: Excessive Sleepiness
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
Narcolepsy, Excessive Daytime Sleepiness
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
This is a double-blind, randomized, placebo-controlled, multicenter trial of NLS-2 in adult patients with narcolepsy. The study will enroll approximately 60 patients and eligible patients will be treated to receive either NLS-2…
- Conditions
- Narcolepsy, Excessive Daytime Sleepiness, Cataplexy Narcolepsy
- Trial name
- NCT04923594
- Testing
- mazindol extended release
- Where
- 22 sites in United States
- Volunteers
- 67 people
- Sponsor
- NLS Pharmaceutics
Excessive Somnolence
VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness
The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.
- Trial name
- NCT00467441
- Testing
- VSF-173
- Where
- France
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vanda Pharmaceuticals
Wakefulness Disorder, Narcolepsy
Hypersomnia in the Paediatric Population
This is a 36-month, multicentric, cross-sectional study involving a paediatric population aged 6 to 17 years. Three groups will be included: Group A: children from the general population with no complaints of sleepiness; Group B…
- Conditions
- Wakefulness Disorder, Narcolepsy, Idiopathic Hypersomnia
- Trial name
- SOMNO-PED (NCT07766343)
- Testing
- Sleepness and wakeness scale, Polysomnography, Actimetry
- Where
- France
- Volunteers
- 760 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
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
Endometriosis, Sleep
Sleep Quality, Daytime Sleepiness and Insomnia in Patients With Endometriosis: a Case-control Study.
This study included women referred to two academic centres for the diagnosis and treatment of endometriosis (cases) and women referred to our Institutions because of routine gynaecologic consultations (controls).
- Trial name
- NCT02027142
- Testing
- Pittsburgh Sleep Quality Index., Epworth sleepiness scale., Insomnia Severity Index.
- Where
- 2 sites in Italy
- Volunteers
- 290 people
- Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Narcolepsy
This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.
This is a study to determine the effect of multiple doses of an investigational drug, taken by mouth, in people with Narcolepsy-cataplexy.
- Trial name
- NCT05015673
- Testing
- SEP363856
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Narcolepsy Type 1, Narcolepsy With Cataplexy
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1
The goal of this clinical trial is to see how NLS-2 (mazindol extended-release) works on symptoms of narcolepsy, including cataplexy and excessive daytime sleepiness.
- Trial name
- AMAZE (NCT05914194)
- Testing
- NLS-2
- Volunteers
- 48 people
- Sponsor
- NLS Pharmaceutics
Idiopathic Hypersomnia, POTS - Postural Orthostatic Tachycardia Syndrome
Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome
The investigators hope to learn if low sodium oxybate (LXB) is an effective treatment for symptoms of idiopathic hypersomnia (IH) and postural tachycardia syndrome (POTS).
- Trial name
- NCT07077278
- Testing
- Low sodium oxybate (LXB)
- Volunteers
- 25 people
- Sponsor
- Stanford University
Parkinson's Disease, Sleep Disorder; Excessive Somnolence
Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence
Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness.
- Trial name
- NCT01338649
- Testing
- Bright Light Treatment (Sun Ray Sunbox SB-558), Dim red light (Sun Ray Sunbox SB-558)
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Northwestern University
Excessive Daytime Sleepiness, Narcolepsy
Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and…
- Conditions
- Excessive Daytime Sleepiness, Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
- Trial name
- NCT00228566
- Testing
- Armodafinil
- Where
- 43 sites in United States
- Volunteers
- 247 people
- Sponsor
- Cephalon
Intensive Care Unit (ICU), Sleep Disruption
Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients
Sleep disturbances are common among intensive care unit (ICU) patients and have been associated with difficult weaning from invasive mechanical ventilation, with an increased risk of endotracheal intubation.
- Conditions
- Intensive Care Unit (ICU), Sleep Disruption, Sleep Monitoring
- Trial name
- MEDICOSLEEP (NCT07606495)
- Testing
- Sleepscan device, Sleep-guided nursing care
- Where
- 7 sites in France
- Volunteers
- 460 people
- Sponsor
- Poitiers University Hospital
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
Hypersomnia, Idiopathic
Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is characterized by non-restoring night-time sleep, excessive daytime sleepiness, sleep inertia, impaired cognitive functioning and autonomic symptoms.
- Trial name
- IDAHO (NCT05150977)
- Testing
- Polysomnography
- Where
- Sweden
- Volunteers
- 69 people
- Sponsor
- Uppsala University
Stress, Fatigue
Title: Effect of Therapeutic Touch on Daytime Sleepiness, Stress and Fatigue
Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery. Design: Randomized placebo-controlled study.
- Conditions
- Stress, Fatigue, Sleepiness
- Trial name
- NCT04515381
- Testing
- Therapeutic Touch, Control group
- Where
- Turkey (Türkiye)
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Mardin Artuklu University
Obstructive Sleep Apnea (OSA), Insomnia
Validating the Use of a Subjectively Reported Sleep Vital Sign
Sleep disorders are commonly under-recognized in the primary care setting and available screening tools are often are limited. The study inestigators hypothesize that the use of a novel subjective sleep vital sign (VS) will…
- Conditions
- Obstructive Sleep Apnea (OSA), Insomnia, Restless Leg Syndrome (RLS), Hypersomnia Type; Sleep Disorder
- Trial name
- SVS (NCT03018912)
- Testing
- Sleep VS
- Where
- United States
- Volunteers
- 1,260 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
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
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
Obstructive Sleep Apnea, Daytime Sleepiness
Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea
This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.
- Trial name
- NCT06395181
- Testing
- Whole Food Plant-Based Diet
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Mayo Clinic
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