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Home Apnea Testing in CHildren Trial (HATCH)

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
In-lab polysomnography
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

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
  • Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care
  • Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

  • Children who have had a PSG within 3 years of enrollment
  • 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

  • The Children's Hospital of PhiladelphiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HSAT first

PSG first

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

Proportion of participants with diagnosis of OSA on both HSAT and PSG
Obstructive sleep apnea (OSA) defined as an obstructive apnea hypopnea index of greater than 2 events/hour on both home sleep apnea test (HSAT) and polysomnography (PSG).

Secondary Outcome Measures

Association between therapeutic decision from HSAT compared to PSG
Logistic regression will compare therapeutic decision (conservative management versus active treatment) from home sleep apnea test (HSAT) or polysomnography (PSG) by investigator blinded to the result of the alternate test.
Proportion of participants who prefer HSAT to PSG
Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG
Obstructive apnea hypopnea index will be assessed as a continuous variable with polysomnography (PSG) assigned as the reference test compared to home sleep apnea test (HSAT).

Full Information

First Posted
May 16, 2022
Last Updated
March 30, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05382754
Brief Title
Home Apnea Testing in CHildren Trial
Acronym
HATCH
Official Title
Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial will compare home sleep apnea testing with the gold standard in-lab polysomnography in terms of 1) accuracy, 2) therapeutic decision-making, and 3) parent/child acceptability in children referred for evaluation of obstructive sleep apnea.
Detailed Description
In-lab attended polysomnography (PSG) is recommended for the diagnosis of obstructive sleep apnea (OSA) in children, but testing is limited by high cost and limited facilities. 90% of children who undergo adenotonsillectomy to treat OSA never have the diagnosis made by PSG. Home sleep apnea testing (HSAT) is an accepted means of evaluating adults for OSA. However, in children there is insufficient evidence comparing HSAT to PSG, so it is not currently recommended in the pediatric population. This single-center comparative effectiveness trial will compare the diagnostic accuracy of HSAT with PSG and will assess the agreement in therapeutic decision-making between the two tests and parent- and child-reported acceptability of HSAT and preference of test. Participants will be randomized to the initial test (HSAT or PSG) and then complete the alternate test within one week. Off-site investigators who are pediatric sleep medicine physicians will provide a therapeutic decision based on clinical data and either HSAT or PSG data, and families will complete questionnaires assessing acceptability of HSAT and preference between the two tests.

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 one week.
Masking
InvestigatorOutcomes Assessor
Masking Description
The investigators will be masked as to the order of the two sleep tests
Allocation
Randomized
Enrollment
317 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HSAT first
Arm Type
Experimental
Arm Description
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
Arm Title
PSG first
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)
In-lab polysomnography
Other Intervention Name(s)
PSG
Intervention Description
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.
Primary Outcome Measure Information:
Title
Proportion of participants with diagnosis of OSA on both HSAT and PSG
Description
Obstructive sleep apnea (OSA) defined as an obstructive apnea hypopnea index of greater than 2 events/hour on both home sleep apnea test (HSAT) and polysomnography (PSG).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Association between therapeutic decision from HSAT compared to PSG
Description
Logistic regression will compare therapeutic decision (conservative management versus active treatment) from home sleep apnea test (HSAT) or polysomnography (PSG) by investigator blinded to the result of the alternate test.
Time Frame
2 weeks
Title
Proportion of participants who prefer HSAT to PSG
Description
Parents of participants will report which test they prefer and both parent and child will report acceptability of home sleep apnea test
Time Frame
2 weeks
Title
Correlation between obstructive apnea hypopnea index (OAHI) of HSAT compared to PSG
Description
Obstructive apnea hypopnea index will be assessed as a continuous variable with polysomnography (PSG) assigned as the reference test compared to home sleep apnea test (HSAT).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female children age 5-12 years old inclusive Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria: Children who have had a PSG within 3 years of enrollment 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
Christopher M Cielo, DO
Phone
2674265748
Email
cieloc@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ignacio E Tapia, MD
Phone
2674265748
Email
tapia@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
The 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
Email
cornaglia@chop.edu
First Name & Middle Initial & Last Name & Degree
Christopher M Cielo, DO
First Name & Middle Initial & Last Name & Degree
Ignacio E Tapia, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Home Apnea Testing in CHildren Trial

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