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

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.

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 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). ^{1 2 3 4 5}

How 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. ^{1 2 3 5 6}

Research Team

Christopher Cielo, MD

Principal Investigator

Children's Hospital of Philadelphia

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.

Parental/guardian permission (informed consent) and if appropriate, child assent.

Referred for diagnostic PSG at the Children's Hospital of Philadelphia (CHOP) Sleep Laboratory for evaluation of OSA as part of clinical care

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Differences between manual and automatic analysis in determining the severity of obstructive sleep apnea using home sleep apnea testing. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

A Modified Definition for Obstructive Sleep Apnea in Home Sleep Apnea Testing after Stroke or Transient Ischemic Attack. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Patient satisfaction with sleep study experience: findings from the Sleep Apnea Patient-Centered Outcomes Network. [2020]

5. Germany 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. [2019]

6. Germany 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? [2020]