Home Apnea Testing in CHildren Trial

Sleep Apnea, Obstructive Clinical Trial

— HATCH  

Official title:

Home Sleep Apnea Testing Compared to In-lab Polysomnography for the Evaluation of Obstructive Sleep Apnea in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382754
• Other study ID #: 21-019533
• Secondary ID: 1R61HL162839-01
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2023
• Est. completion date: July 2027

Study information

• Verified date: February 2024
• Source: Children's Hospital of Philadelphia
• Contact: Christopher M Cielo, DO
• Phone: 2674265748
• Email: cieloc[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 317
• Est. completion date: July 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Dyssomnias
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• Home sleep apnea test
Level II home sleep apnea testing evaluates for obstructive sleep apnea in the home environment with parental supervision.
• In-lab polysomnography
Overnight sleep study in the sleep laboratory with continuous monitoring by clinical staff.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Heart, Lung, and Blood Institute (NHLBI), University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 weeks
Secondary	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.	2 weeks
Secondary	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	2 weeks
Secondary	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).	2 weeks