CompletedNot Applicable

Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients

United States11 participantsStarted 2017-12-28

Plain-language summary

The purpose of the study is: 1) To assess the feasibility of unmonitored polysomnography and 2) to compare apnea hypopnea index (AHI), average SPO2, and SPO2 nadir between unmonitored polysomnography and in-laboratory polysomnography in pediatric patients.

Who can participate

Age range5 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 5- to 12-years-old * Parental informed consent * Suspected Sleep Disordered Breathing Exclusion Criteria: * Developmental delay * Use of home oxygen * History of Parasomnia (e.g. narcolepsy, restless leg syndrome, somnambulism) * History of tracheal surgery * History of tracheal stenosis * History of Nocturnal Hypoventilation * History of Central Sleep Apnea * Use of a Ventilatory Assist Device (e.g. Non-Invasive Positive Pressure Ventilation)

What they're measuring

Greater Than or Equal to 6 Hours of Sleep Data

Timeframe: greater than or equal to 6 hours

Trial details

NCT IDNCT03473548

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-14

Results submitted2021-06-09

View on ClinicalTrials.gov More Sleep Apnea, Obstructive trials