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HSAT for OSA Management in Children (HOM-Kids)

Primary Purpose

Sleep Apnea, Obstructive, Sleep Disorder, Sleep Apnea Syndromes

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Home sleep apnea test

PSG

About this trial

This is an interventional diagnostic trial for Sleep Apnea, Obstructive focused on measuring obstructive sleep apnea, home sleep apnea testing

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HSAT prior to clinical sleep study

PSG first Participants will be random

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correlation between OAHI from HSAT and score from OSA questionnaires

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

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

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

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.

Full Information

NCT ID

NCT05516524

First Posted

August 23, 2022

Last Updated

December 6, 2022

Sponsor

Children's Hospital of Philadelphia

Collaborators

American Academy of Sleep Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05516524

Brief Title

HSAT for OSA Management in Children

Acronym

HOM-Kids

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

August 31, 2025 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital of Philadelphia

Collaborators

American Academy of Sleep Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

obstructive sleep apnea, home sleep apnea testing

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

Investigator

Masking Description

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

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HSAT prior to clinical sleep study

Arm Type

Experimental

Arm Description

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

Arm Title

PSG first Participants will be random

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Home sleep apnea test

Other Intervention Name(s)

Nox A1, HSAT

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

PSG

Other Intervention Name(s)

In-Lab Polysomnography

Intervention Description

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

Primary Outcome Measure Information:

Title

Correlation between obstructive apnea hypopnea index (OAHI) by HSAT vs PSG

Description

Correlation will be assessed in all participants completing PSG and HSAT using the OAHI from both tests

Time Frame

up to one month

Secondary Outcome Measure Information:

Title

Correlation between OAHI from HSAT and score from OSA questionnaires

Description

Time Frame

up to one month

Title

Parent-reported preference between HSAT and PSG

Description

Time Frame

up to one month

Title

Child-reported preference between HSAT and PSG

Description

Time Frame

up to one month

Title

Parent-reported acceptability of HSAT

Description

Time Frame

up to one month.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Anne Cornaglia

Phone

2674265748

cornaglia@chop.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher M Cielo, DO

Organizational Affiliation

Children's Hospital of Philadelphia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Anne Cornaglia

Phone

267-426-5748

cornaglia@chop.edu

12. IPD Sharing Statement

Plan to Share IPD

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HSAT for OSA Management in Children

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