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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two tests in diagnosing sleep apnea in children who have had their tonsils and adenoids removed. The goal is to determine if a home sleep apnea test (HSAT) matches the accuracy of the standard overnight lab test (PSG) for detecting sleep apnea after surgery. Children aged 5-12 who have undergone this surgery for sleep apnea may be suitable candidates. The trial aims to help doctors identify the best test for monitoring the condition post-surgery. As an unphased trial, it offers participants a unique chance to contribute to research that could enhance post-surgery care for children with sleep apnea.

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 prior data suggests that these sleep tests are safe for children?

Research shows that home sleep apnea tests (HSAT) are generally well-tolerated by children. A review of studies found that about two-thirds reported reliable results when using HSAT for children with obstructive sleep apnea (OSA). However, evidence is insufficient to directly compare HSAT to the standard in-lab tests, known as polysomnography (PSG), in children. While HSAT is commonly used for adults, researchers continue to study its safety and effectiveness in children.

Overall, HSAT appears to be a reasonable option for diagnosing sleep apnea in children, with no major safety concerns reported. However, since it remains under study, anyone considering joining a trial should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of home sleep apnea testing (HSAT) for diagnosing pediatric sleep apnea, which could offer a more convenient and accessible alternative to traditional in-lab polysomnography (PSG). While PSG is the current standard and involves an overnight stay in a sleep lab with numerous sensors, HSAT allows for the testing to be done in the comfort of the child's home, potentially increasing comfort and reducing anxiety. This trial aims to determine if HSAT can provide reliable results comparable to PSG, ultimately making sleep apnea diagnosis more accessible and less disruptive for families.

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

Research has shown that home sleep apnea tests (HSAT) can accurately diagnose obstructive sleep apnea (OSA) in children. One study found that HSAT effectively detects moderate to severe OSA using specific measurement guidelines. This suggests HSAT could be a helpful tool for diagnosing sleep apnea in children who are developing normally. Another study examined various portable sleep monitors and found they work well for identifying sleep apnea in kids. In this trial, participants will undergo HSAT either before or after their clinical, in-lab sleep study, known as polysomnography (PSG). While HSAT might not fully replace the more detailed PSG, it offers a practical option for many children. ^{1 2 6 7 8}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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 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]

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12198842/

Randomised trial of home sleep apnoea testing compared ... This single-centre trial compares HSAT to PSG for the diagnosis of OSA in children, including those with DS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05382754

NCT05382754 | Home Apnea Testing in CHildren 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, ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.9650

Clinical application of home sleep apnea testing in children Using HSAT, we clinically applied cutoff values to identify moderate to severe obstructive sleep apnea in typically developing children.

4. otl.stanford.edu otl.stanford.edu/researchers/high-impact-technology-hit-fund/hit-portfolio%23lifesciences/pediatric-sleep-apnea

Pediatric Sleep Apnea Testing Device - Stanford OTL We've developed a groundbreaking home testing device for pediatric sleep apnea, addressing a critical gap in current healthcare practices.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1087079224000959

Diagnostic accuracy of portable sleep monitors in pediatric ... This study systematically reviews the literature addressing the diagnostic accuracies of type III and IV PSM for pediatric sleep apnea.

6. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11792

Home sleep testing in children: we probably can, but should we? There are some data that more than 1 obstructive apnea per hour of sleep is statistically abnormal, but several studies of the consequences of pediatric OSA do ...

7. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A434/8135752

1002 Practice Trends in Pediatric Home Sleep Test Utilization A recent systematic review identified 62 studies, 66.7% of which demonstrated high diagnostic reliability for OSA when using Type III HSAT in children.

8. chop.edu chop.edu/research-studies/home-sleep-apnea-testing-children-hatch-study

Home Sleep Apnea Testing in Children (HATCh) Study The purpose of this research is to compare home sleep apnea testing (HSAT) to in-lab overnight sleep study.