HSAT for OSA Management in Children

NCT05516524 | Completed FDA Device

• 1 other identifier: 22-020232
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Apnea, Obstructive; Sleep Disorder; Sleep Apnea Syndromes; Sleep Disturbance

Keywords

obstructive sleep apnea; home sleep apnea testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Correlation between OAHI from HSAT and score from OSA questionnaires

  up to one month

• Parent-reported preference between HSAT and PSG

  up to one month

• Child-reported preference between HSAT and PSG

  up to one month

• Parent-reported acceptability of HSAT

  up to one month.

Study Arms (2)

HSAT prior to clinical sleep study

EXPERIMENTAL

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

Diagnostic Test: Home sleep apnea test

PSG first Participants will be random

ACTIVE COMPARATOR

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

Diagnostic Test: PSG

Interventions

Home sleep apnea test DIAGNOSTIC_TEST

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

Also known as: Nox A1, HSAT

HSAT prior to clinical sleep study

PSG DIAGNOSTIC_TEST

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

Also known as: In-Lab Polysomnography

PSG first Participants will be random

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children age 5-12 years old inclusive
• History of adenotonsillectomy for OSA

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

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MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders; Sleep Apnea Syndromes; Parasomnias

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Christopher M Cielo, DO

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators will be masked as to the order of the two sleep tests
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to the initial test (home sleep apnea test or polysomnography) and then complete the alternate test within approximately one week.

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: December 1, 2022
• Primary Completion: September 10, 2025
• Study Completion: September 17, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)