Clinical trials: Sleep-Wake Disorders
Cognitive, Mood and Cognitive Performance
The Acute Effects of Onnit Alpha Brain on Cognition and Mood States
The purpose of this randomized, double-blind, placebo-controlled crossover study is to evaluate the efficacy of the acute effects of an investigational supplement (Alpha Brain or Alpha Brain 2.0) on improving cognitive…
- Conditions
- Cognitive, Mood and Cognitive Performance, Sleep Deprivation, Executive Function (Cognition)
- Trial name
- NCT07495592
- Testing
- Alpha Brain proprietary cognitive dietary supplement, Alpha Brain 2.0 proprietary cognitive dietary supplement
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Applied Science & Performance Institute
Sleep Disorder (Healthy Volunteers)
Study to Evaluate Improvements of the Quality of Sleep With NOVANUIT® Triple Action in Healthy Volunteers With Sleep Disorders
Primary Objective: To estimate the range of improvement of NOVANUIT® triple action on sleep quality global score. Secondary Objectives: To estimate the range of improvement of NOVANUIT® triple action on following parameters: time…
- Trial name
- NCT03514732
- Testing
- MELATONIN (MELATL07959)
- Where
- Poland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sanofi
Restless Legs Syndrome
Effect on RLS Symptom Severity After Switching to Neupro® in Patients Who Previously Experienced Augmentation
The objective is to assess the effect of Neupro® on the severity of Restless Leg Syndrome (RLS) symptoms and augmentation in patients with augmentation associated with previous oral dopaminergic therapy.
- Trial name
- AURORA (NCT01386944)
- Where
- 18 sites in Germany
- Volunteers
- 102 people
- Sponsor
- UCB Pharma
Snoring, Sleep Disorder
Efficacy and Safety Study of Nasal Lubricant Compared to Placebo on Snoring
Pivotal clinical trial, multicenter of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of nasal lubricant on snoring.
- Trial name
- RONCO (NCT05031585)
- Testing
- Roncoliv
- Where
- Brazil
- Volunteers
- 90 people
- Sponsor
- Brainfarma Industria Química e Farmacêutica S/A
Obstructive Sleep Apnea
Pediatric Nasal Mask Usability Study
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
- Trial name
- NCT01154322
- Testing
- Pixi pediatric mask
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea
The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous…
- Trial name
- TESLA-MICRON (NCT07343362)
- Testing
- ZeusOSA, CPAP
- Volunteers
- 186 people
- Sponsor
- Zeus Sleep Ltd
Central Sleep Apnea
Post Approval Study of the remedē System
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
- Trial name
- NCT03425188
- Where
- 17 sites in United States, Germany
- Volunteers
- 53 people
- Sponsor
- Respicardia, Inc.
ADHD, Narcolepsy
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant…
- Trial name
- SEAL (NCT04647903)
- Testing
- ADAIR 10 mg IR tablets, d-amphetamine sulfate
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Vallon Pharmaceuticals, Inc.
Sleep Disorder
A Double-blind Placebo Controlled Trial of Sentra PM, a Medical Food
This is a double blind placebo controlled study of one hundred and four subjects which will be randomized for treatment with Sentra PM alone, Sentra PM with trazadone, trazadone alone and placebo alone.
- Trial name
- NCT01468038
- Testing
- Trazodone, Sentra PM, Sentra PM and Trazodone (CoPack Kit Trazamine)
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Targeted Medical Pharma
Insomnia Disorder
A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder
The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese…
- Trial name
- NCT07677384
- Testing
- HS-10506
- Volunteers
- 600 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sleep Apnea, Obstructive
Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)
The purpose of this engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy.
- Trial name
- PBSW (NCT01031914)
- Testing
- Paced Breathing
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea
A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
- Trial name
- EliSA (NCT04031040)
- Testing
- Genio® system therapy
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea
PAP-NAP Device Clinical Study
This exploratory pilot study will evaluate the usability and short-term tolerability of a novel positive airway pressure (PAP) device in adults during a supervised daytime nap session in a simulated sleep environment.
- Trial name
- NCT07785310
- Testing
- APL Device
- Volunteers
- 10 people
- Sponsor
- ResMed
Obstructive Sleep Apnea, Obstructive Sleep Apnea-hypopnea
Updating Deep Learning Algorithms for OSA Monitoring
The objective is to enhance the reliability of the algorithm to match that of Level 1 polysomnography by leveraging the diverse data obtained from Level 1 polysomnography to refine the deep learning algorithm.
- Trial name
- NCT06522815
- Testing
- CART-I plus, Polysomnography
- Where
- South Korea
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- Sky Labs
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
- Trial name
- NCT03156413
- Testing
- F&P nasal mask
- Where
- New Zealand
- Volunteers
- 12 people
- Sponsor
- Fisher and Paykel Healthcare
Narcolepsy With Cataplexy, Narcolepsy
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.
- Conditions
- Narcolepsy With Cataplexy, Narcolepsy, Narcolepsy Without Cataplexy
- Trial name
- NCT05055024
- Testing
- Mazindol
- Where
- 22 sites in United States
- Volunteers
- 52 people
- Sponsor
- NLS Pharmaceutics
Insomnia Disorders
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users
The primary purpose of this study is to evaluate the abuse potential of lemborexant (E2006) in comparison to placebo and 2 controls with known abuse potential (ie, zolpidem and suvorexant) with similar indications (zolpidem and…
- Trial name
- NCT03158025
- Testing
- Zolpidem tablets, Suvorexant tablets, over-encapsulated, Lemborexant tablets
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Sleep Deprivation
Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants
This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.
- Trial name
- NCT07848659
- Testing
- HBS-104
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Harmony Biosciences Management, Inc.
Insomnia Disorder
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
The key objectives of this study are to determine, using sleep diaries, whether lemborexant at the doses 5 milligrams (mg) and 10 mg is superior to placebo on subjective sleep onset, subjective sleep efficiency, and subjective…
- Trial name
- NCT02952820
- Testing
- lemborexant
- Where
- 114 sites in United States, Canada and 10 more
- Volunteers
- 971 people
- Sponsor
- Eisai Inc.
Sleep Deprivation
Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation
Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep…
- Trial name
- NCT03182413
- Testing
- Modafinil, THN102
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Theranexus