N/A
Completed N=11
Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients
Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT03473548 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Greater Than or Equal to 6 Hours of Sleep Data — 1 Participants
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.
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 | — |
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. Informational only — not medical advice.