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Completed

NCT Number: NCT05516524

HSAT for OSA Management in Children

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

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorder Sleep Disorders, Intrinsic Sleep Disturbance Sleep Wake Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home sleep apnea test

Diagnostic Test

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

Other names: Nox A1, HSAT

PSG

Diagnostic Test

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

Other names: In-Lab Polysomnography

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • American Academy of Sleep Medicine

Registry information

Official study title

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

Acronym: HOM-Kids

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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