HOM-Kids: HSAT for OSA Management in Children

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05516524

Collaborator

American Academy of Sleep Medicine (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive Sleep Disorder Sleep Apnea Syndromes Sleep Disturbance	Diagnostic Test: Home sleep apnea test Diagnostic Test: PSG	N/A

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

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention 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.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 (Investigator)

Masking Description:

The investigators will be masked as to the order of the two sleep tests

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HSAT prior to clinical sleep study Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography	Diagnostic Test: Home sleep apnea test Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision. Other Names: Nox A1 HSAT
Active Comparator: PSG first Participants will be random Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.	Diagnostic Test: PSG Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff. Other Names: In-Lab Polysomnography

Arm

Intervention/Treatment

Experimental: HSAT prior to clinical sleep study

Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography

Diagnostic Test: Home sleep apnea test

Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.

Other Names:

Nox A1

HSAT

Active Comparator: PSG first Participants will be random

Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.

Diagnostic Test: PSG

Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.

Other Names:

In-Lab Polysomnography

Outcome Measures

Primary Outcome Measures

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

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 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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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