Clinical trials: Sleep Apnea
Sleep Apnea, Sleep Apnea Syndromes in Children
Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations
The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight…
- Conditions
- Sleep Apnea, Sleep Apnea Syndromes in Children, Sleep Apnea Syndromes
- Trial name
- NCT06218186
- Testing
- Medical Device: Wesper Lab Home Sleep Test
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Wesper Inc
Sleep Disorders
Evaluation of WP200 With the Unified Probe (WP200U)
The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated.
- Trial name
- NCT01929447
- Where
- Israel
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Itamar-Medical, Israel
Down Syndrome, Obstructive Sleep Apnea
Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea
This study is a prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow fifty-seven (57) adolescents and young adults (10-21 years of age), with Down syndrome…
- Trial name
- NCT04801771
- Testing
- Inspire Upper Airway Stimulation (UAS) System
- Where
- 8 sites in United States
- Volunteers
- 57 people
- Sponsor
- Inspire Medical Systems, Inc.
Obstructive Sleep Apnea
Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)
The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst.
- Trial name
- NCT01010438
- Where
- 3 sites in Israel
- Volunteers
- 59 people
- Sponsor
- Oridion
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Sleep Apnea, Obstructive
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of obstructive sleep apnea (OSA) in adults..
- Trial name
- NCT03748771
- Testing
- ApneaLink Air
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ResMed
Sleep Disordered Breathing, Obstructive Sleep Apnea
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.
- Conditions
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Central Sleep Apnea
- Trial name
- NCT00922168
- Where
- 2 sites in United States
- Volunteers
- 146 people
- Sponsor
- Cleveland Medical Devices Inc
Respiration
Substantial Equivalence Study for Kai Medical Non-Contact Respiratory Rate Monitors for Use With Neonates
The purpose of this study is to test the accuracy of two devices (the Kai Spot (v 2.1) and the Kai Continuous (v 1.0) that can measure breathing patters (how fast you breath) without wires and without touching the body.
- Trial name
- NCT01324817
- Testing
- Kai Spot (v 2.1), Kai Continuous (v 1.0)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Kai Medical, Inc.
Sleep Apnea
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Obstructive Sleep Apnea of Adult
An Extension Study to Assess the Long-term Safety of the Genio® System
The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a…
- Trial name
- OLE (NCT05939141)
- Testing
- Genio System
- Where
- 7 sites in Australia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
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
Snoring, Apnea, Obstructive
Dental Appliance to Treat SDB in Children
The clinical hypothesis of this study is that a currently marketed mouthguard may also be able to reduce the symptoms of sleep-disordered breathing in children.
- Conditions
- Snoring, Apnea, Obstructive, Upper Airway Resistance Syndrome, Sleep-Disordered Breathing
- Trial name
- NCT05661747
- Testing
- Vivos Grow/Vivos Way Device
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Vivos BioTechnologies, Inc.
Sleep
Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters
The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies.
- Trial name
- NCT02378831
- Volunteers
- healthy volunteers welcome
- Sponsor
- Itamar-Medical, Israel
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
Sleep Apnea
Rainbow Acoustic Monitoring (RAM) Clinical Engineering Data Collection
To capture high resolution waveform data and numerical data from investigational and FDA-released RAM sensors in the neonatal, infant, pediatric, and adult patient population
- Trial name
- NCT03120897
- Testing
- RAM sensor
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Masimo Corporation
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
Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry
Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3)…
- Trial name
- NCT02907398
- Testing
- Inspire therapy, No intervention
- Where
- 64 sites in United States, Belgium and 3 more
- Volunteers
- 5,000 people
- Sponsor
- Inspire Medical Systems, Inc.
Narcolepsy, Obstructive Sleep Apnea
The Nuvigil and Provigil Pregnancy Registry
The primary objective of the Nuvigil/Provigil Pregnancy Registry is to characterize the pregnancy and fetal outcomes associated with Nuvigil and Provigil exposure during pregnancy.
- Conditions
- Narcolepsy, Obstructive Sleep Apnea, Shift Work Sleep Disorder
- Trial name
- NCT01792583
- Testing
- Modafinil/armodafinil
- Where
- United States
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- Cephalon, Inc.
Sleep Disorders
Validation of Home Sleep Testing (WP) Compared to an Overnight Sleep Testing in the Sleep Laboratory
Obstructive sleep apnea syndrome (OSAS) is considered to be a major public health problem. The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated.
- Trial name
- NCT01570738
- Where
- Israel
- Volunteers
- 274 people, healthy volunteers welcome
- Sponsor
- Itamar-Medical, Israel
Obstructive Sleep Apnea, Nasal Congestion
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
1. CPAP compliance will be significantly higher in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase. 2.
- Conditions
- Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion
- Trial name
- Thermosmart (NCT00665977)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Clayton Sleep Insititute