Clinical trials: Apnea
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, Respiratory Insufficiency
Study of the Usability and Efficacy of a New Pediatric CPAP Mask
This study will evaluate a newly developed pediatric mask (known as Pixi) on children aged 2-7 using continuous positive airway pressure (CPAP), or Non-invasive ventilation (NIV) treatment.
- Trial name
- NCT01312948
- Testing
- Prototype mask (known as Pixi)
- Where
- Australia
- Volunteers
- 6 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.
Bronchiolitis, Apnea
Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants
Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea is a complication of bronchiolitis, reported in 16 - 21% of cases.
- Conditions
- Bronchiolitis, Apnea, Caffeine
- Trial name
- NCT01435486
- Testing
- Caffeine citrate, Normal saline
- Where
- Qatar
- Volunteers
- 90 people
- Sponsor
- Hamad Medical Corporation
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.
Respiratory Infections, Bronchiolitis
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
The primary objective of this study is to describe the incidence of RSV-associated LRI among infants <1 year of age presenting to the ED during selected shoulder months.
- Conditions
- Respiratory Infections, Bronchiolitis, Pneumonia, Apnea
- Trial name
- NCT00369759
- Testing
- Emergency Dept. Subjects with LRI or Apnea
- Where
- 38 sites in United States
- Volunteers
- 2,048 people
- Sponsor
- MedImmune LLC
Narcolepsy
Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness
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 obstructive sleep apnea/hypopnea…
- Trial name
- NCT00214968
- Testing
- Modafinil
- Volunteers
- 92 people
- Sponsor
- Cephalon
Seizures, Urticaria and Angioedema
A Safety Study For Prevenar 13 Among Chinese Children
This is an observational study based on a population-based EHR database.
- Conditions
- Seizures, Urticaria and Angioedema, Apnea, Fever
- Trial name
- NCT03656939
- Where
- China
- Volunteers
- 21,240 people
- Sponsor
- Pfizer
Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal
Continuous Monitoring of Lung Ventilation
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation.
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal, Apnea, Respiration Disorders
- Trial name
- NCT00810186
- Where
- 3 sites in Israel
- Volunteers
- 77 people
- Sponsor
- Pneumedicare Ltd.
Pediatric Obstructive Sleep Apnea, Down Syndrome (DS)
Pediatric Down Syndrome Post-Approval Study
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea.
- Trial name
- NCT06851338
- Testing
- Hypoglossal Nerve Stimulation
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Inspire Medical Systems, Inc.
Blood Oxygen Desaturations, Sleep-Disordered Breathing
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep.
- Trial name
- WAGSC1 (NCT04886583)
- Testing
- Gabi Baby Band
- Where
- 3 sites in Belgium
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
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
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
Obstructive Sleep Apnea
Validation and Usability Study of the SleepView+ Home Sleep Testing System for the Evaluation of Moderate to Severe Obstructive Sleep Apnea.
The goal of this observational study is to characterize the performance of the SleepView+ home sleep test system for the evaluation of moderate to severe obstructuve sleep apnea (OSA) in adult and pediatric patients (ages 12 and…
- Trial name
- NCT07476313
- Testing
- SleepView+
- Where
- 4 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Beacon Biosignals
Lysosomal Storage Disease, Lung Diseases
Biomarker for Maroteaux-Lamy Disease (BioMaroteaux)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Maroteaux-Lamy disease from blood
- Conditions
- Lysosomal Storage Disease, Lung Diseases, Obstructive Sleep Apnoea, Macroglossia
- Trial name
- BioMaroteaux (NCT01458613)
- Where
- 5 sites in Egypt, Germany and 2 more
- Sponsor
- CENTOGENE GmbH Rostock
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, Pediatric Sleep Apnea
Wearable Technologies for Sleep in Children and Adolescents
This study aims to evaluate the viability of wearable and portable technologies for sleep staging in children and adolescents. The results will be compared with polysomnography, in order to achieve clinical and diagnostic…
- Trial name
- NCT06237842
- Testing
- Diagnostic Test: EEG headband+Ring oximeter (RO)+Actigraphy (ACT)
- Where
- Brazil
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- SleepUp Tecnologia em Saúde Ltda
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, 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