N/A
N=11
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT03473548 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Greater Than or Equal to 6 Hours of Sleep Data — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Portable sleep monitor (Device); In-laboratory Polysomnography (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Greater Than or Equal to 6 Hours of Sleep Data |
1 | — |
| SECONDARY Apnea Hypopnea Index (AHI) Score |
1 | — |
| SECONDARY SPO2 Result |
1 | — |
| SECONDARY SPO2 Nadir |
1 | — |
| SECONDARY McGill Oximetry Score |
1 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03473548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.