Sleep Apnea Clinical Trial
Official title:
A Single Arm Quantitative Study Assessing Performance of Wesper Lab as a Tool to Aid in 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 polysomnography (PSG) evaluation in a pediatric population (subjects 2 to 21 years of age). The main question[s] it aims to answer are: - Does Wesper Lab demonstrate agreement with PSG for the calculation of the apnea/hypopnea index (AHI)? - Does Wesper Lab demonstrate agreement with PFG for the calculation of sleep apnea severity. Participants that are already undergoing a prescribed PSG for the detection of sleep apnea will be asked to simultaneously wear the Wesper Lab sensors and an FDA approved pulse oximeter. Researchers will compare the AHI of Wesper Lab to the AHI of the PSG to determine the accuracy of the Wesper Lab device. This is a single center, single-arm, quantitative study
This is a single center, single-arm, quantitative study evaluating the effectiveness of the Wesper Lab, previously known as TatchSleep Pro, wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight polysomnography (PSG) evaluation in a pediatric population. Investigators will identify approximately 150 eligible pediatric patients, 50 subjects per subgroup, who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. Subgroups include pediatric patients in the following age ranges: subgroup 1: 2-5 years old, subgroup 2: 6-11 years old, subgroup 3: 12-21 years old. After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential (12 years or older) will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study. Patients will undergo their PSG test while simultaneously wearing 2 Wesper Lab patches and an FDA-cleared pulse oximeter compatible with and connected to the Wesper Lab system for a single night at the clinic. The same make and model of pulse oximeter will be used for all subjects. Patients will be observed overnight by trained sleep technicians who will setup the Wesper Lab device and collect the sleep data via the companion smartphone application. A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events. Following the data collection, sleep data from PSG and Wesper Lab will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of Wesper Lab compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the Wesper Lab data to obtain an estimate of inter-rater reliability. Accuracy of the Wesper Lab device will be demonstrated by comparing the Pearson correlation of Wesper Lab and PSG AHI to a performance goal. The performance goal is based on a meta-analysis of FDA-cleared similar devices. Fisher's transformation and one-sided Z-test will be used to test the hypotheses with a significance level of 0.025. The upper and lower 95% Bland-Altman limits of agreement will be calculated and statistically compared using a Wald test to performance goals based on a meta-analysis of FDA-cleared similar devices. Deming regression will also be presented. The inter-rater reliability of Wesper Lab AHIs will be calculated. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
| Recruiting |
NCT03919955 -
A Novel Pharmacological Therapy for Obstructive Sleep Apnea
|
Phase 2 | |
| Completed |
NCT03927547 -
Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
|
N/A | |
| Recruiting |
NCT04007380 -
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
|
N/A | |
| Completed |
NCT02188498 -
Electrocardiography Data Analysis in Sleep Disorders
|
||
| Completed |
NCT01503164 -
Effects of Continuous Positive Airway Pressure (CPAP) on Glucose Metabolism
|
N/A | |
| Recruiting |
NCT00747890 -
Surgical Treatment of Mild Obstructive Sleep Apnea
|
N/A | |
| Active, not recruiting |
NCT00738179 -
Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea to Prevent Cardiovascular Disease
|
Phase 3 | |
| Completed |
NCT00841906 -
Alice PDx User/Validation Extended Trial
|
N/A | |
| Completed |
NCT00202501 -
Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome
|
N/A | |
| Completed |
NCT00047463 -
Effects of Treating Obstructive Sleep Apnea in Epilepsy
|
Phase 2 | |
| Not yet recruiting |
NCT06029881 -
Portable System for Non-intrusive Monitoring of Sleep
|
||
| Recruiting |
NCT06093347 -
Central Apnoea Monitor Study
|
||
| Terminated |
NCT05445869 -
Severe OSA Study (SOS)
|
N/A | |
| Withdrawn |
NCT04096261 -
The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
|
||
| Recruiting |
NCT04575740 -
Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea
|
N/A | |
| Completed |
NCT04676191 -
Validation of a Contactless Vital Signs Measurement Sensor
|
N/A | |
| Recruiting |
NCT06015620 -
Comorbidities Resolution After MGB Surgery and Change in Body Composition
|
||
| Completed |
NCT06051097 -
Metabolic Syndrome and Obstructive Sleep Apnea
|
||
| Recruiting |
NCT05687097 -
Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
|