HSAT for OSA Management in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Home Sleep Apnea Testing for the Evaluation of Obstructive Sleep Apnea in Children Following Management With Adenotonsillectomy

Conditions
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Sleep Apnea, Obstructive, Sleep Disorder, Sleep Apnea Syndromes, Sleep Disturbance

Intervention / Treatment
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* Diagnostic Test: Home sleep apnea test
* Diagnostic Test: PSG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within approximately one week.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSAT prior to clinical sleep study<br>Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography | Diagnostic Test: Home sleep apnea test<br>* Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.<br>* Other names: HSAT;|
| Active Comparator: PSG first Participants will be random<br>Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography. | Diagnostic Test: PSG<br>* Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.<br>* Other names: In-Lab Polysomnography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG | Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests | up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between OAHI from HSAT and score from OSA questionnaires | Correlation between OAHI from HSAT will be measured by completion of the Pediatric Sleep Questionnaire-Sleep Related Breathing Disorders scale (PSQ-SRBD) and OSA-18 Questionnaire. . The PSQ-SRBD is a 22-item questionnaire where a score of >0.33 is consistent with a diagnosis of OSA. The OSA-18 consists of 18 questions for which the overall total scores will assess for OSA risk. Total scores range from 18 to 126, with 18 indicating low risk of OSA and 126 indicating high risk of OSA. | up to one month | 
| Parent-reported preference between HSAT and PSG | Parent-reported preference between HSAT and PSG will be measured by the parents' completion of the preference questionnaire after completion of both studies. The questionnaire contains 5 questions for which the overall score will assess for preference. Total scores range from 5 to 10, with 5 indicating a strong preference for HSAT and 10 indicating a low preference for HSAT. | up to one month | 
| Child-reported preference between HSAT and PSG | Child-reported preference between HSAT and PSG will be measured by the child's completion of the preference questionnaire after completion of both studies. The questionnaire contains 5 questions for which the overall score will assess for preference. Total scores range from 5 to 10, with 5 indicating a strong preference for HSAT and 10 indicating a low preference for HSAT. | up to one month | 
| Parent-reported acceptability of HSAT | Parent-reported acceptability of HSAT will be measures by the parents' completion of the acceptability questionnaire after completion of both studies. The questionnaire contains 4 questions for which the overall score will assess for preference. Total scores range from 4 to 20, with 4 indicating a strong preference for HSAT and 20 indicating a low preference for HSAT. | up to one month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, home sleep apnea testing