Sleep Tests for Pediatric Sleep Apnea (HOM-Kids 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
Trial Summary
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
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.
178910Is 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.
25679What 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.
34679Do 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.
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.
Participant Groups
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).
2Treatment groups
Experimental Treatment
Active Control
Group I: HSAT prior to clinical sleep studyExperimental Treatment1 Intervention
Participants will be randomized to undergo HSAT before receiving their clinical, in-lab polysomnography
Group II: PSG first Participants will be randomActive 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:
Children's Hospital of PhiladelphiaPhiladelphia, PA
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
American Academy of Sleep MedicineCollaborator
References
[Reliability of respiratory polygraphy for the diagnosis of sleep apnea-hypopnea syndrome in children]. [2008]Overnight polysomnography (PSG) is the gold standard diagnostic tool for sleep apnea-hypopnea syndrome (SAHS) in children. The aim of the present study was to evaluate the usefulness of diagnostic respiratory polygraphy in children with clinically suspected SAHS referred to our sleep-disordered breathing clinic.
Predictors of Obstructive Sleep Apnea on Polysomnography after a Technically Inadequate or Normal Home Sleep Test. [2018]Home sleep testing (HST) is an accepted alternative to polysomnography (PSG) for diagnosing obstructive sleep apnea (OSA) in high-risk populations. Clinical guidelines recommend PSG in cases where the HST is technically inadequate (TI) or fails to establish the diagnosis of OSA in patients with high pretest probability. This retrospective study evaluated predictors of OSA on PSG within patients who had a TI or normal HST.
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.
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.
Predictors of Obstructive Sleep Apnea on a Home Sleep Apnea Test After a Negative Attended Polysomnography. [2019]A home sleep apnea test (HSAT) is an acceptable alternative to polysomnography (PSG) for the diagnosis of obstructive sleep apnea (OSA) in patients with high pretest probability without certain comorbidities, such as severe pulmonary disease, congestive heart failure, or neuromuscular weakness. Current guidelines recommend repeat in-laborataory PSG in those with an initial negative PSG and high clinical suspicion for OSA. This retrospective study evaluated predictors of OSA on HSAT in patients who had a negative PSG.
Clinical application of home sleep apnea testing in children: a prospective pilot study. [2023](1) To determine the sensitivity and specificity of the home sleep apnea test (HSAT) performed in typically developing children who were diagnosed with moderate to severe obstructive sleep apnea during overnight attended laboratory polysomnography (LPSG). (2) To determine the utility of a screening questionnaire to identify children at increased risk for obstructive sleep apnea.
Comparing in-lab full polysomnography for diagnosing sleep apnea in children to home sleep apnea tests (HSAT) with an online video attending technician. [2022]The main study aim was to compare the validity of children sleep apnea data obtained from standard polysomnography (PSG) to a home sleep apnea test (HSAT) accompanied by an attending online video technician. Our study population was comprised of 100 children, 54 boys and 46 girls, ages 3-11 (average age 5.2, SD 1.2) assigned randomly either to in-lab full PSG or to a HSAT with real-time, online technical support to rule out obstructive sleep apnea (OSA). A t test comparison did not yield significant differences between data obtained from the in-lab PSG and HSAT with real-time, online, technical support for any of the following measures: Apnea-Hypopnea Index, Oxygen desaturation Index, baseline O2, or minimum O2 parameters. However, a significant difference was found for time in bed and total sleep time, which was significantly longer in the HAST. Online HSAT can provide a safe, convenient and a reliable way to perform sleep studies in young children for diagnosing OSA in their familiar home environment.
Telehealth-supported level 2 pediatric home polysomnography. [2023]The gold standard for diagnosis of pediatric obstructive sleep apnea (OSA) is level 1 polysomnography (PSG). At our centre, some children are selected for unattended level 2 home sleep apnea testing (HSAT) with telehealth support, and we sought to review this home service.
Two nights of home polysomnography in healthy 7-14-year-old children - Feasibility and intraindividual variability. [2023]Attended polysomnography (PSG) is the gold standard for childhood sleep evaluation. There is, however, only limited information regarding repeated ambulatory PSG in children. We aimed to test whether in hospital attached level 2 home PSG is feasible and reproducible in healthy children.