At-Home Sleep Tests or Overnight Lab Trip for Kids?

In many parts of the country, children and their parents face months-long wait times for sleep tests at labs. With obesity rising among the pediatric population, at-home sleep tests to assess sleep apnea and other disorders may be a more accessible and less expensive option.

But regulators have only approved a few home sleep apnea tests (HSATs) for use in children, and the American Academy of Sleep Medicine (AASM) has not recommended any of these products. What is a pediatrician to do?

“There has been a growing need for home sleep testing in children as access to in-lab polysomnography is getting increasingly difficult due to both pediatric staff and center shortages,” Anuja Bandyopadhyay, MD; Lynn D’Andrea, MD; and Christopher Cielo, DO, liaison, chair, and vice chair, respectively, of the AASM Task Force working on an update to clinical guidelines on the use of HSAT for the diagnosis of obstructive sleep apnea (OSA) in children, told Medscape Medical News in an email.

The prevalence of OSA in children ranges from 2% to 6%, with a higher incidence in those with obesity and other comorbidities. The condition is primarily caused by enlarged tonsils and adenoids. Removal of the obstructing tissue is the most common treatment. If surgery is not indicated, continuous positive airway pressure (CPAP) may be used.

OSA can increase the risk for cardiovascular disease and sleep fragmentation, which affects cognition and daily functioning. Surgery to remove the tonsils may also not resolve severe OSA because of underlying medial complexities or genetic disorders.

The most recent guidelines in 2017 from the AASM, whose members include sleep centers and sleep medicine professionals, stated that not enough evidence existed at the time to recommend the clinical use of HSAT in children. One concern was that the devices were prone to generating false-negative findings and could underestimate cases of OSA, said D’Andrea, medical director of the Pediatric Sleep Center at the Medical College of Wisconsin/Children’s Wisconsin in Milwaukee.

The AASM Task Force said it will update guidance on HSAT in 2025, taking into consideration more recent research. Binal Kancherla, MD, program chairperson of the Section on Pediatric Pulmonology and Sleep Medicine Executive Committee at the American Academy of Pediatrics, said most general pediatricians do not have expertise in assessing results from home tests or dealing with failed studies.

“There always needs to be an option to perform an in-lab study if the at-home test is inconclusive or doesn’t provide the data that is needed,” Kancherla said. “Eventually, it can be a bridge to getting the testing done and getting started on treatment earlier.”

Potential Limitations, Needing In-Lab Test Anyway

HSATs are typically purchased by physicians or sleep centers, which provide the products to patients. Parents put the equipment on their child at night and email the data to the physician, who downloads and interprets the results.

Home tests do not provide all the information that an in-lab test can. HSATs measure respiration, air flow, oxygen levels, and body movements, which correlate to how much a child is sleeping. But a lab test provides more data points, such as carbon dioxide measurements, said Rakesh Bhattacharjee, MD, section chief of sleep medicine in the Division of Respiratory Medicine at University of California San Diego. In addition, in-lab tests include results from an EEG, which can help determine sleep patterns; most at-home tests do not, he said.

Other challenges can occur with at-home tests. While an in-lab technician monitors signals to make sure sensors do not fall off or the nasal cannula is not taken out inadvertently, parents usually do not monitor children in the same way, Bhattacharjee said.

“My concern about home sleep testing is mostly when it fails,” Bhattacharjee stated. “How many more times do we try again until we call it a day? And then if we call it a day, what happens to these kids?”

While tonsillectomy is the first-line treatment for children, about 20% of children will still have OSA after the procedure, Bhattacharjee said. In this case, CPAP may be warranted, but children will need an in-lab study to receive confirmation of diagnosis for insurers to reimburse the device.

Still, home sleep tests are used more frequently by pediatricians due to the rise in obesity. A home test can be a fast and effective way to make a diagnosis and get a patient started on treatment, Kancherla, medical director of the Children’s Sleep Center at Texas Children’s Hospital in Houston, said.

Kancherla said her center receives 90 referrals per day. The wait time for a study is typically 6 months. In 2023, the center conducted approximately 6000 polysomnography studies and about 20 home tests, the latter of which were primarily on children older than 14 years who had obesity and did not have other major medical problems.

“But there is no correlation between weight, age, degree of snoring, and severity of sleep apnea in any aged children,” Kancherla said.

One study noted that obesity is a risk factor for the development of OSA in children. One increment in body mass index (BMI) above the 50th percentile was associated with a 10% increased risk for OSA, the research showed. But no data currently show BMI correlates to severity of OSA, Kancherla said.

Efficacy

Device makers have attempted to recreate in-lab polysomnography with the same sensors in a home environment. Some newer machines have different sensors, such as accelerometry and photoplethysmography, which are commonly found in consumer wearable devices such as smartwatches, Cielo, director of the Sleep Center in the Division of Pulmonary & Sleep Medicine at Children’s Hospital of Philadelphia, said.

“Many devices now utilize a computer-based scoring system of collected data rather than the human-scored interpretations that have long been the standard for sleep apnea testing,” Cielo said.

However, he said few studies have been done comparing the accuracy of at-home devices with in-lab tests for the diagnosis of OSA in children.

The devices also do not undergo the same process as new prescription drugs by the US Food and Drug Administration (FDA). Designated as class II devices, the agency reviews data to determine if a product is “substantially” equivalent to another already on the market.

One recent study in Journal of Clinical Sleep Medicine reviewed literature on the performance, operating mechanisms, strengths, and limitations of several HSATs.

“While the optimal moment for the widespread adoption of OSA-detecting wearables may not have yet arrived, their role is undeniably set to rapidly expand in the foreseeable future,” the authors stated. “In the interim, sleep clinicians should embrace these emerging tools, gain insights into the capabilities and constraints of these devices, and scrutinize the available data.”

They noted that the absence of research validating devices in the pediatric population highlights the need for further studies on these products.

Pediatric devices cleared by the FDA include MyCardio’s SleepImage System, Caldwell Industries’ ApneaTrak, and SOMNOmedics GmbH’s SOMNOscreen plus, which are all authorized for use in children older than 2 years. Itamar Medical’s WatchPAT ONE is cleared for use in children older than 12 years. Most devices the FDA has authorized for marketing to aid in diagnosis of sleep disorders are for adults.

Cost As a Factor

The cost of an in-lab sleep study varies based on the facility, age of the patient, type of test performed, and insurance coverage. According to the national, independent nonprofit FAIR Health, the median charge for a patient who is uninsured or obtaining the service out-of-network ranges from $3315 to $11,066, which includes facility and provider costs. For those who are insured and stay in-network, the median allowed amount (the total fee negotiated between an insurance plan and a provider for an in-network service) ranges from $1412 to $6529. At-home tests range between $150 and $500.

In-lab polysomnography for children is covered by most insurers, but most private insurers require preauthorization. Insurers typically do not cover home tests for children, said Bandyopadhyay, an assistant professor of clinical pediatrics at the Indiana University School of Medicine in Indianapolis.

Still, Troy Pridgeon, MyCardio’s director of US sales, said his company has heard from parents trying to find clinicians who can provide the device for at-home testing, often because they are more affordable and accessible than in-lab tests.

The company has observed a steady increase in use of the SleepImage System since the device hit the market in August 2019 by primary care clinicians, pediatricians, ear nose and throat specialists, and dentists, Pridgeon said. The SleepImage PO6 Ring, which has a list price of $299, is sold exclusively to healthcare providers who can either lend or sell the device to parents.

The software app that facilitates data collection and delivery to the SleepImage System is free to download and use, but generating a report requires a subscription. Pridgeon said insurers usually do not cover the cost of the hardware.

SleepImage has several products for monitoring accelerometer and oximeter data, including a ring placed on a child’s finger that streams data to a mobile app on a phone. The app uploads the data to the SleepImage System, which a clinician reviews.

“Children simply don’t have time to wait until their teenage or adult years to have their sleep evaluated,” said Solveig Magnusdottir, MD, chief medical officer and co-founder of MyCardio.

Magnusdottir contends that there is a need for simpler tests like SleepImage and WatchPAT, which are cleared for automatic analysis of data in simple reports that are easy for the nonsleep specialist to interpret.

“Based on economics, a home sleep test should be step 1, and then if there are issues that surface during the home sleep test, the next step needed may be a PSG,” she said.

Brenda Sandburg is a freelance journalist who writes about the FDA, the biopharmaceutical industry, and legal issues for the Pink Sheet and American Lawyer Media.