Sleep Tests for Pediatric Sleep Apnea

(HOM-Kids Trial)

Overseen By Yaelis Roman-Rosado, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Hypoventilation, Hypoxemia, Tracheostomy, others

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

Compensation: Varies

Number of Visits: 2

Duration: up to one month

60 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Home sleep apnea test for pediatric sleep apnea?

Research shows that home sleep apnea tests (HSAT) are a good alternative to in-lab sleep studies for diagnosing obstructive sleep apnea in children, especially when they have a high chance of having the condition. These tests are more comfortable and cost-effective, and they have been found to be accurate in identifying sleep apnea. ^{1 2 3 4 5}

Is home sleep apnea testing safe for children?

Home sleep apnea testing (HSAT) is generally considered safe for diagnosing sleep apnea in children, as it is a non-invasive procedure that can be done at home with telehealth support. ^{2 3 4 6 7}

How is the home sleep apnea test (HSAT) treatment for pediatric sleep apnea different from other treatments?

The home sleep apnea test (HSAT) is unique because it allows children to be tested for sleep apnea in the comfort of their own home, with the support of telehealth or online video technicians, making it more convenient and less stressful compared to traditional in-lab polysomnography (PSG). This approach provides reliable results similar to in-lab tests, but with longer sleep times due to the familiar environment. ^{2 3 8 9 10}

What is the purpose of this trial?

This clinical trial will compare the diagnostic accuracy of type II HSAT with PSG for determining OSA status following treatment with adenotonsillectomy in children

Research Team

Christopher Cielo, MD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for boys and girls aged 5-12 who have had surgery to remove their tonsils and adenoids (adenotonsillectomy) to treat sleep apnea. It's not for kids with a tracheostomy, those living without a parent in a facility, or those needing extra oxygen or air pressure during sleep.

Inclusion Criteria

I have had surgery to remove my tonsils and adenoids for sleep apnea.

I am a child aged between 5 and 12 years old.

Exclusion Criteria

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

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

My child needs extra oxygen or help to breathe, especially during sleep.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo HSAT and PSG to evaluate OSA status following adenotonsillectomy

up to one month

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Home sleep apnea test
• PSG

Trial Overview The study is checking if a home sleep apnea test (HSAT) can accurately tell if children still have obstructive sleep apnea after having their tonsils and adenoids removed, compared to the standard lab test called polysomnography (PSG).

Participant Groups

Group I: HSAT prior to clinical sleep study Experimental Treatment 1 Intervention

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

Group II: PSG first Participants will be random 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+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Findings from Research

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 retrospective audit of 233 children aged 5-18 years showed that telehealth-supported home sleep apnea testing (HSAT) achieved a technical success rate of nearly 90%, indicating it is a reliable alternative for diagnosing pediatric obstructive sleep apnea (OSA).

The study found that 89.5% of patients obtained at least 6 hours of sleep during testing, and parental feedback indicated high satisfaction with the care and convenience of the telehealth service, suggesting strong family acceptability of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth-supported level 2 pediatric home polysomnography. Griffiths, A., Mukushi, A., Adams, AM.[2023]

The home sleep apnea test (HSAT) demonstrated a sensitivity of 71.43% and specificity of 95.83% for identifying moderate to severe obstructive sleep apnea in children, based on a study of 38 participants who underwent both HSAT and laboratory polysomnography.

The SHOOTS questionnaire, which assesses risk factors for sleep apnea, showed a sensitivity of 85.7% and specificity of 54.2% for identifying children at risk for obstructive sleep apnea, suggesting it could be a useful screening tool before conducting HSAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical application of home sleep apnea testing in children: a prospective pilot study. Revana, A., Vecchio, J., Guffey, D., et al.[2023]

In a study of 141 patients who had a negative polysomnography (PSG) for obstructive sleep apnea (OSA), 83.7% were diagnosed with OSA using a subsequent home sleep apnea test (HSAT), indicating that PSG can sometimes yield false negatives.

Older age and the presence of hypertension were significant predictors for a positive OSA diagnosis on HSAT after an initial negative PSG, suggesting that these factors should be considered when evaluating patients for repeat testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Obstructive Sleep Apnea on a Home Sleep Apnea Test After a Negative Attended Polysomnography. Lipatov, K., Hayek, A., Ghamande, S., et al.[2019]

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 of 238 patients who underwent home sleep testing (HST) followed by polysomnography (PSG), 76% of those with a normal HST had a normal PSG, indicating that younger patients with normal HST results are likely to not have obstructive sleep apnea (OSA).

Conversely, among patients with a technical inadequate (TI) HST, 71% were diagnosed with OSA on subsequent PSG, highlighting the importance of PSG for confirming OSA in cases where HST results are inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Obstructive Sleep Apnea on Polysomnography after a Technically Inadequate or Normal Home Sleep Test. Zeidler, MR., Santiago, V., Dzierzewski, JM., et al.[2018]

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 study involving 100 children aged 3-11 found that home sleep apnea tests (HSAT) with online technical support provided results comparable to standard polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA).

The HSAT allowed for longer total sleep time and time in bed compared to PSG, suggesting that it is a safe and convenient option for conducting sleep studies in a familiar home environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing in-lab full polysomnography for diagnosing sleep apnea in children to home sleep apnea tests (HSAT) with an online video attending technician. Green, A., Nagel, N., Kemer, L., et al.[2022]

In a study of 53 children suspected of having sleep apnea-hypopnea syndrome (SAHS), respiratory polygraphy showed an 84.9% agreement rate with the gold standard overnight polysomnography, indicating its reliability as a diagnostic tool.

The study found that respiratory polygraphy can effectively diagnose SAHS in children, with specific cutoff values for respiratory disturbance index (RDI) varying by age, suggesting tailored approaches for different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reliability of respiratory polygraphy for the diagnosis of sleep apnea-hypopnea syndrome in children]. Alonso Alvarez, ML., Terán Santos, J., Cordero Guevara, JA., et al.[2008]

A study involving 33 healthy children aged 7-14 demonstrated that level 2 polysomnography (PSG) conducted at home is feasible and produces high-quality data, with a mean sleep efficiency of 94% and an average total sleep time of 8.4 hours.

The study found no significant differences in sleep quality or nocturnal urine production between nights with PSG and nights without, indicating that the PSG process does not negatively impact sleep, and there was no first night effect observed in the PSG variables.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two nights of home polysomnography in healthy 7-14-year-old children - Feasibility and intraindividual variability. Pedersen, MJ., Leonthin, H., Mahler, B., et al.[2023]

References

1. 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]

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

Telehealth-supported level 2 pediatric home polysomnography. [2023]

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

Clinical application of home sleep apnea testing in children: a prospective pilot study. [2023]

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

Predictors of Obstructive Sleep Apnea on a Home Sleep Apnea Test After a Negative Attended Polysomnography. [2019]

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

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

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

Predictors of Obstructive Sleep Apnea on Polysomnography after a Technically Inadequate or Normal Home Sleep Test. [2018]

7. 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]

8. Japan pubmed.ncbi.nlm.nih.gov

Comparing in-lab full polysomnography for diagnosing sleep apnea in children to home sleep apnea tests (HSAT) with an online video attending technician. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

[Reliability of respiratory polygraphy for the diagnosis of sleep apnea-hypopnea syndrome in children]. [2008]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Two nights of home polysomnography in healthy 7-14-year-old children - Feasibility and intraindividual variability. [2023]