HSAT for OSA Management in Children

Not Applicable

Recruiting

• Conditions: Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea Syndromes; Sleep Disturbance
• Interventions: Diagnostic Test: PSG; Diagnostic Test: Home sleep apnea test

• Registration Number: NCT05516524
• Lead Sponsor: Children's Hospital of Philadelphia

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 Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-25
• Study Start: 2022-12-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-08-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PSG first Participants will be random	PSG	Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.
HSAT prior to clinical sleep study	Home sleep apnea test	Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography

Primary Outcome Measures

Name	Time	Method
Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG	up to one month	Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests

Secondary Outcome Measures

Name	Time	Method
Parent-reported preference between HSAT and PSG	up to one month	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.
Correlation between OAHI from HSAT and score from OSA questionnaires	up to one month	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.
Parent-reported acceptability of HSAT	up to one month.	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.
Child-reported preference between HSAT and PSG	up to one month	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.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States