HSAT for OSA Management in Children (HOM-Kids)

October 10, 2025 updated by: Children's Hospital of Philadelphia

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

This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between OAHI from HSAT and score from OSA questionnaires
Time Frame: 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.
up to one month
Parent-reported preference between HSAT and PSG
Time Frame: 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.
up to one month
Child-reported preference between HSAT and PSG
Time Frame: 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.
up to one month
Parent-reported acceptability of HSAT
Time Frame: 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.
up to one month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

American Academy of Sleep Medicine

Investigators

  • Principal Investigator: Christopher M Cielo, DO, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

September 10, 2025

Study Completion (Actual)

September 17, 2025

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 10, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-020232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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