Clinical trials: Sleep Disorders, Intrinsic
Sleep Apnea
Janus II Feasibility
The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.
- Trial name
- NCT06556693
- Testing
- Dual Channel Stimulation
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zoll Medical Corporation
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
Insomnia
Study of Efficacy of WELT-IP in Insomnia (WCTP-I-B-02)
The purpose of the study was to determine safety and efficacy of WELT-IP in adult insomnia patients. WELT-IP is a cognitive behavioral therapy for insomnia (CBT-I) based digital therapeutics.
- Trial name
- NCT05809544
- Testing
- WELT-IP
- Where
- South Korea
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- WELT corp
Stillbirth, Infant, Low Birth Weight
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty…
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing
- Trial name
- NCT04437407
- Testing
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Chronic Pain, Insomnia
The Efficacy of CALPXT96™in Improving Sleep Quality in Patients With Chronic Non-cancer Pain
California Poppy has been traditionally used in Herbal Medicine as an analgesic, mild sedative and/or sleep aid. However there are no human clinical trial data to support its use.
- Trial name
- CALPXT96 (NCT02232256)
- Testing
- CALPXT96
- Where
- Canada
- Sponsor
- 9305-9954 Quebec Inc
Insomnia
Remote STATE Training for Insomnia in Older Adults
This study called rSTATE (Remote STATE Training for Insomnia in Older Adults) is a Phase II study to definitively evaluate the efficacy of a computerized cognitive training program (rSTATE) designed to improve sleep regulation…
- Trial name
- rSTATE (NCT06589024)
- Testing
- Computerized Plasticity-Based Adaptive Cognitive Training, Sleep Hygiene Education
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Posit Science Corporation
Primary Insomnia
A Study of Gaboxadol in Primary Insomnia
To evaluate the safety and tolerability of gaboxadol in primary insomnia.
- Trial name
- NCT00209846
- Testing
- Gaboxadol
- Where
- Sweden
- Volunteers
- 320 people
- Sponsor
- H. Lundbeck A/S
Narcolepsy
A Study to Evaluate the Safety and Efficacy of TS-091 in Patients with Narcolepsy
The purpose of this study is to investigate the efficacy and safety after administration of TS-091 compared with placebo in patients with narcolepsy.
- Trial name
- NCT03267303
- Testing
- TS-091 5mg, TS-091 10mg
- Where
- 2 sites in Japan, South Korea
- Volunteers
- 53 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
Sleep Apnea, Obstructive
eXciteOSA for Treatment of Moderate Obstructive Sleep Apnea
The objective of this study is to assess the efficacy of the eXciteOSA device amongst a sample of patients with moderate OSA. The study is a multi-center, prospective, open-label, randomized, parallel-arm trial of eXciteOSA…
- Trial name
- ELMO (NCT05252156)
- Testing
- eXciteOSA
- Where
- 7 sites in United States
- Volunteers
- 62 people
- Sponsor
- Signifier Medical Technologies
Obstructive Sleep Apnea Syndrome
Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M CadCam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea (OSA) Therapy: ESTAMPS Study
ESTAMPS is a randomized clinical trial with a crossover design: Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design)…
- Trial name
- ESTAMPS (NCT02755662)
- Testing
- Mandibular Retention Device
- Where
- France
- Volunteers
- 12 people
- Sponsor
- ResMed
Sleep Apnea Syndrome
Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)
The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.
- Trial name
- NCT00942669
- Testing
- SleepStrip OTC(TM)
- Where
- Israel
- Volunteers
- 80 people
- Sponsor
- Scientific Laboratory Products, Ltd.
Sleep Disordered Breathing (SDB), Sleep Apnea
Neurostimulation for Sleep Disordered Breathing (SDB)
This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Trial name
- ECLIPSE 2 (NCT07243405)
- Testing
- Neuro stimulator implant
- Where
- Panama
- Volunteers
- 45 people
- Sponsor
- Lunair Medical
Sleep Apnea
Prodigy, a Level 2 Sleep Study Device, Validation Study
The Prodigy system, developed by Cerebra Medical Ltd, allows for the generation of the same information in the home that is currently only obtained in in-laboratory studies.
- Trial name
- NCT05115305
- Where
- 2 sites in United States, Canada
- Volunteers
- 84 people
- Sponsor
- Cerebra Medical
Obstructive Sleep Apnea Syndrome
Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome
Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with Obstructive Sleep Apnea Syndrome (OSAS). The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during attended…
- Trial name
- AL539 (NCT01441622)
- Testing
- AL539 (SRETT)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Air Liquide Santé International
RLS
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe…
- Trial name
- RLS (NCT02633683)
- Testing
- HORIZANT 600 mg
- Where
- 11 sites in United States
- Volunteers
- 144 people
- Sponsor
- XenoPort, Inc.
Sleep Disorder
A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders
The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders.
- Trial name
- NCT06093633
- Where
- 3 sites in United States, Israel
- Volunteers
- 600 people
- Sponsor
- Itamar-Medical, Israel
Obstructive Sleep Apnea
TPAP for Comfort in OSA
TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what…
- Trial name
- NCT06264128
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- SleepRes Inc.
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
Chronic Insomnia
A Study of Ramelteon in Chinese Patients With Chronic Insomnia
The purpose of this study is to assess the efficacy and safety of Ramelteon in chinese patients with chronic insomnia. Efficacy will be evaluated on objective and subjective sleep parameters.
- Trial name
- NCT06512363
- Testing
- Ramelteon
- Volunteers
- 280 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
Respiratory Insufficiency, Sleep Disordered Breathing
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure.
- Trial name
- NCT01403584
- Testing
- AutoVPAP with addition of AutoEPAP, AutoVPAP with EPAP manually selected
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- ResMed
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