Home vs Lab Sleep Apnea Testing for Sleep Apnea

(HATCH Trial)

Overseen By Christopher M Cielo, DO

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Down syndrome, Hypoventilation, Hypoxemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

317 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare home sleep apnea tests with traditional in-lab sleep studies for children with suspected sleep apnea, a condition where breathing stops and starts during sleep. Researchers seek to determine if home tests are as accurate, assist doctors in making treatment decisions, and provide more comfort for families. The trial includes two groups: one starts with the home test, the other with the lab test. Children ages 5-12 who are already scheduled for a sleep study at the Children's Hospital of Philadelphia may be suitable candidates. As an unphased trial, this study offers families the chance to contribute to research that could make sleep studies more accessible and comfortable for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these sleep apnea testing methods are safe for children?

Research has shown that home sleep apnea tests (HSAT) are safe. These tests are already used to diagnose obstructive sleep apnea in adults. Many studies indicate that HSAT is as effective as traditional in-lab tests, especially for straightforward cases. The American Academy of Sleep Medicine recommends HSAT for certain patients.

HSAT is non-invasive, meaning it doesn't enter the body. It monitors breathing, heart rate, and oxygen levels during sleep. Most people find it comfortable due to its non-intrusive nature. There are no reports of major side effects or safety issues with HSAT. Its convenience and ease of use at home contribute to its popularity.

Overall, HSAT provides a safe and effective way to diagnose sleep apnea without requiring a hospital visit. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's comparing home sleep apnea testing (HSAT) to the traditional in-lab sleep study, or polysomnography (PSG). The HSAT offers the convenience of testing in the comfort of your own home, which can be less intimidating and more accessible for patients. This method could make diagnosing sleep apnea easier and more affordable, potentially leading to earlier detection and treatment for more people. By comparing these two approaches, researchers hope to determine if the home test is as effective as the lab test, which could revolutionize how sleep apnea is diagnosed in the future.

What evidence suggests that this trial's methods could be effective for sleep apnea?

Research has shown that home sleep apnea tests (HSAT), one of the methods under study in this trial, can effectively identify obstructive sleep apnea (OSA). These tests allow people to easily monitor their breathing and oxygen levels at home, increasing accessibility. However, some studies suggest that HSAT might not fully capture the severity of sleep apnea because it doesn't track different sleep stages, which help measure total sleep time. Despite this limitation, HSAT remains a valuable tool for diagnosing OSA. This trial will compare HSAT with traditional in-lab polysomnography (PSG) to evaluate their effectiveness in diagnosing OSA. ^{6 7 8 9 10}

Who Is on the Research Team?

Christopher Cielo, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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.

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

My child has a tracheostomy or a connection between the trachea and skin.

My child had a sleep study within the last 3 years.

I am a child living in a facility without my parent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Testing

Participants are randomized to undergo either home sleep apnea testing (HSAT) or in-lab polysomnography (PSG) as the initial test

1 week

1 visit (in-person or at home)

Alternate Testing

Participants complete the alternate test (HSAT or PSG) within one week of the initial test

1 week

1 visit (in-person or at home)

Follow-up

Participants are monitored for safety and effectiveness after testing, and families complete questionnaires assessing acceptability and preference

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Home sleep apnea test
• In-lab polysomnography

Trial Overview 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.

How Is the Trial Designed?

Group I: HSAT first Experimental Treatment 1 Intervention

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

Group II: PSG first Active Control 1 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

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study of 2563 sleep apnea patients, those who underwent in-lab polysomnography (PSG) reported higher satisfaction with their testing experience (71%) compared to those who had home sleep apnea testing (HSAT) (60%), indicating a significant difference in patient acceptance between the two methods.

The study found that patients with HSAT had 38% lower odds of satisfaction compared to those with PSG, even after adjusting for factors like symptom severity and CPAP satisfaction, suggesting that real-world experiences may differ from previous research findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient satisfaction with sleep study experience: findings from the Sleep Apnea Patient-Centered Outcomes Network. Kapur, VK., Johnston, JC., Rueschman, M., et al.[2020]

In a study analyzing 838 diagnostic sleep tests, 26.4% of patients with obstructive sleep apnea (OSA) were found to be reclassified to a less severe category when the apnea-hypopnea index (AHI) was recalculated using time in bed instead of total sleep time, indicating a significant risk of underestimating OSA severity.

The risk of misclassification was particularly high among older patients, with 40.3% of moderate OSA cases and 36.0% of severe OSA cases being downgraded to milder categories, which could impact treatment decisions and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Underestimation of Sleep Apnea Severity by At-Home Kits: Rescoring In-Laboratory Polysomnography Without Sleep Staging. Bianchi, MT., Goparaju, B.[2018]

A single channel frontal EEG was validated against full EEG during polysomnography, showing a high agreement (92-95%) in scoring sleep versus wake, which suggests it could improve accuracy in sleep assessments.

In a study of 207 home sleep apnea tests (HSATs), the absence of EEG monitoring led to a 20% overestimation of sleep time and an 8% false-negative rate for obstructive sleep apnea (OSA) diagnoses, particularly affecting patients with insomnia or low sleep efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addition of frontal EEG to adult home sleep apnea testing: does a more accurate determination of sleep time make a difference? Light, MP., Casimire, TN., Chua, C., et al.[2020]

Type IV portable monitors (PMs) show variable sensitivity (67.5-100%) and specificity (25-100%) for diagnosing obstructive sleep apnea (OSA) compared to the gold standard polysomnography (PSG), indicating that while they can be useful, their accuracy may not be reliable enough for standalone clinical use.

The review included 24 studies with 2068 patients, suggesting that while type IV PMs could improve access to OSA diagnosis, careful consideration of their diagnostic limitations is necessary to avoid potential misdiagnoses that could impact patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of level IV portable sleep monitors versus polysomnography for obstructive sleep apnea: a systematic review and meta-analysis. Abrahamyan, L., Sahakyan, Y., Chung, S., et al.[2019]

In a study of 198 patients, automatic analysis (AA) of home sleep apnea testing (HSAT) showed moderate concordance with manual analysis (MA) for diagnosing obstructive sleep apnea hypopnea syndrome (OSAHS), but weak concordance for severity classification, indicating potential inaccuracies in AA.

The AA underestimated the apnea-hypopnea index (AHI) by an average of 8 events per hour and misclassified the severity of OSAHS in 47% of cases, suggesting that reliance on AA could lead to inappropriate treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences between manual and automatic analysis in determining the severity of obstructive sleep apnea using home sleep apnea testing. Labarca, G., Dreyse, J., Salas, C., et al.[2019]

A modified definition of obstructive sleep apnea (OSA) that includes lower apnea-hypopnea indices (AHI 5-14.9) and oxygen desaturation (≤88%) led to a greater reduction in daytime sleepiness, as measured by the Epworth Sleepiness Scale, after starting CPAP treatment.

This modified definition did not negatively impact CPAP compliance rates or the accuracy of scoring sleep apnea, suggesting it could be a beneficial approach for patients with a history of stroke or transient ischemic attack.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modified Definition for Obstructive Sleep Apnea in Home Sleep Apnea Testing after Stroke or Transient Ischemic Attack. Patel, N., Raissi, A., Elias, S., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3525988/

PRO: Sliding into Home: Portable Sleep Testing Is Effective ... Portable methods have been evaluated for diagnosis of OSA. Testing for OSA in the home only solves half of the problem.

2. aasm.org aasm.org/advancements-in-home-sleep-apnea-tests-bridging-convenience-and-clinical-effectiveness/

Advancements in home sleep apnea tests A home sleep apnea test (HSAT) provides more accessible options for SRBD diagnosis, particularly obstructive sleep apnea (OSA). Companies have ...

3. hopkinsmedicine.org hopkinsmedicine.org/health/wellness-and-prevention/what-to-know-about-an-at-home-sleep-test

What to Know About an At-Home Sleep Test A home sleep apnea test is a very simplified breathing monitor that tracks your breathing, oxygen levels, and breathing effort while worn.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5359331/

Potential Underestimation of Sleep Apnea Severity by At- ... The kits are known to underestimate sleep apnea severity, in part because of lack of sleep staging to provide total sleep time. Study Impact: The results ...

5. uptodate.com uptodate.com/contents/home-sleep-apnea-testing-for-obstructive-sleep-apnea-in-adults/print

Home sleep apnea testing for obstructive sleep apnea in adults Limited data suggest comparable clinical outcomes when type 3 and type one devices were compared [3]. In-laboratory devices. Type 1 devices ( ...

6. mayoclinic.org mayoclinic.org/medical-professionals/pulmonary-medicine/news/home-sleep-apnea-test-simplifies-diagnosing-obstructive-sleep-apnea/mac-20483343

Home sleep apnea test simplifies diagnosing obstructive ... Many studies show equivalence of outcomes to those of two-night test protocols. "By utilizing split-night studies, scoring them in real-time ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6287732/

Clinical Use of a Home Sleep Apnea Test A home sleep apnea test (HSAT) is an alternative to polysomnography for the diagnosis of OSA in uncomplicated adults presenting with signs and symptoms.

8. aasm.org aasm.org/aasm-releases-position-statement-home-sleep-apnea-testing/

AASM Home Sleep Apnea Testing (HSAT) Position ... A new position statement published by the American Academy of Sleep Medicine (AASM) describes the appropriate clinical use of a home sleep apnea test (HSAT).

9. northwell.edu northwell.edu/news/insights/at-home-sleep-study-what-you-need-to-know

At-home sleep study: Everything you need to know An at-home sleep study monitors your breathing, heart rate, oxygen levels, and other vital signs while you sleep. The popularity of these tests, ...

10. uptodate.com uptodate.com/contents/home-sleep-apnea-testing-for-obstructive-sleep-apnea-in-adults

Home sleep apnea testing for obstructive sleep apnea in adults In select patients with OSA, home sleep apnea testing (HSAT; also referred to as out-of-center sleep testing or portable monitoring) can be ...