Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG
Study Overview
Brief Summary
This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children
Detailed Description
Many children have residual obstructive sleep apnea (OSA) following adenotonsillectomy, but in-lab polysomnography (PSG), the recommended means of re-evaluating these patients, is resource-intensive and availability is limited. Home sleep apnea testing (HSAT), a similar test performed in the patient's home and used clinically in adults, may offer an alternative means of evaluating the effect of OSA treatment in children and make testing more convenient and widely available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Masking Description
The investigators will be masked as to the order of the two sleep tests
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female children age 5-12 years old inclusive
- •History of adenotonsillectomy for OSA
Exclusion Criteria
- •Children with a history of hypoventilation or hypoxemia or who require supplemental oxygen or positive airway pressure during sleep
- •Children with a tracheostomy or tracheocutaneous fistula
- •Children who live in a facility without their parent
Arms & Interventions
HSAT prior to clinical sleep study
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
Intervention: Home sleep apnea test (Diagnostic Test)
PSG first Participants will be random
Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.
Intervention: PSG (Diagnostic Test)
Outcomes
Primary Outcomes
Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG
Time Frame: up to one month
Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests
Secondary Outcomes
- Parent-reported preference between HSAT and PSG(up to one month)
- Correlation between OAHI from HSAT and score from OSA questionnaires(up to one month)
- Parent-reported acceptability of HSAT(up to one month.)
- Child-reported preference between HSAT and PSG(up to one month)