N/A
Completed N=20
Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children
Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT03748771 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography) — 6.2; 10.9; 11.6; 16.9 events per hour
Summary
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..
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography) |
6.2; 10.9; 11.6; 16.9; 18.6; 13.5 | — |
| SECONDARY Patient Satisfaction |
12; 4; 1 | — |
| SECONDARY Number of Successful HST Evaluations |
15; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Patients presenting with symptoms of OSA needing a sleep study
- Patients between the ages of 12 and 17 years, inclusive
Exclusion Criteria
- Patients less than 12 years old
- Patients 18 years old or older
- Children with syndromes or congenital disease including Down Syndrome, Prader-Willi syndrome, children with craniofacial disorders, and finally children with congenital heart disease or pulmonary hypertension
Data sourced from ClinicalTrials.gov (NCT03748771). 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.