Home vs Lab Sleep Apnea Testing for Sleep Apnea (HATCH Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Hospital of Philadelphia
No Placebo Group
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
What data supports the effectiveness of home sleep apnea testing (HSAT) for diagnosing sleep apnea?
Home sleep apnea testing (HSAT) is a more comfortable and cost-effective alternative to in-lab sleep studies for diagnosing obstructive sleep apnea, although it may underestimate the severity of the condition compared to the gold standard in-lab polysomnography (PSG).
12345How is home sleep apnea testing different from other treatments for sleep apnea?
Home sleep apnea testing (HSAT) is unique because it allows patients to be tested for sleep apnea in the comfort of their own home, offering better comfort and lower costs compared to the traditional in-laboratory polysomnography (PSG), which is the current 'gold standard' for diagnosis.
12356Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Eligibility Criteria
This trial is for children aged 5-12 who are being checked for sleep apnea at the Children's Hospital of Philadelphia. They need consent from a parent or guardian, and if old enough, their own agreement to participate. Kids living without parents, with breathing holes in their necks (tracheostomy), serious breathing problems during sleep, or recent sleep studies can't join.Inclusion Criteria
I am a child aged between 5 and 12 years old.
Exclusion Criteria
My child has a tracheostomy or a connection between the trachea and skin.
I am a child living in a facility without my parent.
My child needs extra oxygen or help to breathe, especially during sleep.
Participant Groups
The study is looking at how well home sleep tests work compared to overnight stays at the hospital lab where they watch your child's sleep closely (polysomnography). It checks which method tells us more accurately about sleep issues, helps doctors decide on treatment better, and what kids and parents prefer.
2Treatment groups
Experimental Treatment
Active Control
Group I: HSAT firstExperimental Treatment1 Intervention
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
Group II: PSG firstActive Control1 Intervention
Participants will be randomized to undergo HSAT after receiving their clinical, in-lab polysomnography.
Home sleep apnea test is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Home Sleep Apnea Test for:
- Diagnosis of obstructive sleep apnea (OSA)
- Monitoring of OSA treatment effectiveness
🇪🇺 Approved in European Union as Home Sleep Apnea Test for:
- Diagnosis of obstructive sleep apnea (OSA)
- Monitoring of OSA treatment effectiveness
🇨🇦 Approved in Canada as Home Sleep Apnea Test for:
- Diagnosis of obstructive sleep apnea (OSA)
- Monitoring of OSA treatment effectiveness
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
The Children's Hospital of PhiladelphiaPhiladelphia, PA
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
University of MiamiCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
National Institutes of Health (NIH)Collaborator
References
Potential Underestimation of Sleep Apnea Severity by At-Home Kits: Rescoring In-Laboratory Polysomnography Without Sleep Staging. [2018]Home sleep apnea testing (HSAT) is increasingly available for diagnosing obstructive sleep apnea (OSA). One key limitation of most HSAT involves the lack of sleep staging, such that the respiratory event index is calculated using the total recording time (TRT) rather than total sleep time (TST).
Diagnostic accuracy of level IV portable sleep monitors versus polysomnography for obstructive sleep apnea: a systematic review and meta-analysis. [2019]Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder. In-laboratory, overnight type I polysomnography (PSG) is the current "gold standard" for diagnosing OSA. Home sleep apnea testing (HSAT) using portable monitors (PMs) is an alternative testing method offering better comfort and lower costs. We aimed to systematically review the evidence on diagnostic ability of type IV PMs compared to PSG in diagnosing OSA.
A Modified Definition for Obstructive Sleep Apnea in Home Sleep Apnea Testing after Stroke or Transient Ischemic Attack. [2018]Home sleep apnea testing (HSAT) underestimates obstructive sleep apnea (OSA) severity. Overnight oxygen desaturation has been shown to be a strong predictor of incident stroke, and may be helpful in determining which patients with lower apnea-hypopnea indices (AHIs) should be offered treatment.
Patient satisfaction with sleep study experience: findings from the Sleep Apnea Patient-Centered Outcomes Network. [2020]Home sleep apnea testing (HSAT) is increasingly used as an alternative to laboratory-based polysomnography (PSG) for the diagnosis of obstructive sleep apnea. Patient satisfaction with sleep testing performed at home or in the lab has been sparsely assessed, despite its potentially pivotal role in determining patients' acceptance of sleep apnea treatment. We hypothesize that satisfaction in clinical practice may differ from what has been previously reported within the research setting.
Differences between manual and automatic analysis in determining the severity of obstructive sleep apnea using home sleep apnea testing. [2019]Home sleep apnea testing (HSAT) is a diagnostic measure for obstructive sleep apnea hypopnea syndrome (OSAHS) in moderate/high risk patients. Some HSAT companies contain automatic analysis (AA). However, guidelines recommend manual analysis (MA) despite the weak evidence for this recommendation.
Addition of frontal EEG to adult home sleep apnea testing: does a more accurate determination of sleep time make a difference? [2020]Home sleep apnea testing (HSAT) typically does not include electroencephalogram (EEG) monitoring for sleep assessment. In patients with insomnia and low sleep efficiency, overestimation of the sleep period can result from absence of EEG, which will reduce sleep disordered breathing (SDB) indices and may lead to a false-negative result.