Digital Technology for Sleep Apnea

(HNSLEEP Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Allergies to medical tape, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people experiencing homelessness by diagnosing and treating sleep apnea, a common sleep disorder that disrupts breathing during sleep. The trial employs digital tools, including a portable sleep monitoring device, and treatment options such as a special breathing machine and a dental device, to enhance participants' sleep and overall quality of life. Individuals currently staying in shelters who suspect they might have sleep apnea may be suitable candidates for this study. As an unphased trial, it provides participants the opportunity to access innovative sleep apnea treatments and improve their quality of life.

Will I have to stop taking my current medications?

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

What prior data suggests that this digital technology is safe for diagnosing and treating sleep apnea?

Research has shown that digital devices for diagnosing sleep apnea are generally safe and meet safety standards. Many of these devices, including the Prodigy 2 used in this study, have received approval from health authorities for home use. Their design ensures easy setup and use, minimizing risks. Studies indicate that treatments like Auto-CPAP and Mandibular advancement devices (MAD) are well-tolerated by most patients. These treatments are widely used and have a strong safety record. Reporting any side effects to a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative approaches to diagnosing and treating sleep apnea using digital technology. Unlike traditional methods that often require hospital visits for sleep studies, this trial uses the Prodigy 2, a portable device approved by Health Canada, which allows for easy, at-home sleep monitoring. This device not only records standard metrics like airflow and oxygen levels but also captures detailed brain activity to identify different sleep stages. Additionally, the trial considers patient preferences and uses advanced treatment options like Auto-CPAP and Mandibular advancement devices, potentially leading to more personalized and effective care. By combining these technologies, the trial aims to improve accessibility and accuracy in diagnosing and managing sleep apnea.

What evidence suggests that digital technology is effective for treating sleep apnea in people experiencing homelessness?

This trial will compare different treatment options for sleep apnea. Research has shown that auto-CPAP, one of the treatment options in this trial, effectively aids people with moderate to severe sleep apnea. It improves sleep quality and reduces symptoms like daytime sleepiness and high blood pressure. Using auto-CPAP for at least four hours each night lowers the risk of death compared to not using it.

Mandibular advancement devices (MADs) are another treatment option in this trial for obstructive sleep apnea. They move the lower jaw forward, reducing the severity of sleep apnea. MADs enhance sleep quality and lessen daytime tiredness. Both treatments are effective but operate differently, offering options based on individual needs and preferences. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people experiencing homelessness in Canada who may have sleep disorders, including sleep apnea. It aims to diagnose and treat these conditions to improve their quality of life.

Inclusion Criteria

Residing in a shelter at the time of recruitment

I am older than 18.

Exclusion Criteria

Allergies to medical tape (for diagnosis study)

I need a lot of dental work or have gum disease with loose teeth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Diagnosis

Participants undergo sleep apnea assessment using a portable polysomnography device

1-2 weeks

1 visit (in-person)

Treatment

Participants receive treatment for sleep apnea using Auto-CPAP or Mandibular advancement device

6 months

Monthly follow-ups (virtual or in-person)

Follow-up

Participants are monitored for adherence and effectiveness of treatment

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Digital Technology

Trial Overview The study involves questionnaires, portable polysomnography (a type of sleep study), and treatment for diagnosed sleep disorders. The goal is to see how patient-centered treatment affects the participants' quality of life.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 2 Interventions

Description: Individuals who are diagnosed with sleep apnea, and are deemed eligible for treatment, will receive a treatment option based on Canadian Agency for Drugs and Technologies in Health (CADTH), physician recommendations, and the participant's preferences. In this study, auto-titrating positive airway pressure (Auto-CPAP) and Mandibular advancement device (MAD) will be the main modalities of treatment.

Group II: Screening Experimental Treatment 1 Intervention

Also, the participants are asked to complete the following questionnaires with the help of a research assistant. The result of the application will be combined with the questionnaires for the final risk assessment. * Participant Demographics questionnaire * STOP-Bang * Insomnia severity index * Epworth sleepiness score (ESS) * Functional outcome of Sleep Questionnaire (FOSQ-10) * Beck Depression Inventory (BDI) * Chalder Fatigue Scale (CFQ) * Health Information Technology Usability Evaluation Scale (Health-ITUES) Questionnaire * Oral Health Impact Profile - 14 (OHIP-14) * Asthma Control Test (ACT) * Primary care post-traumatic stress disorder (PTSD) screen (PC-PTSD-5) * A survey to help identify barriers to treatment in the people experiencing homelessness (General Survey)

Group III: Diagnosis Experimental Treatment 2 Interventions

Description: A portable polysomnography device to assess sleep apnea in individuals at risk of sleep apnea. The Prodigy 2 has Health Canada Approval for home sleep study. The system is small, easy to use, and can be setup by a research technician at the shelter. Prodigy measures thoraco-abdominal motion, nasal airflow, oxyhemoglobin saturation (SpO2), cardiac function with electrocardiogram and leg movement. The main advantage of Prodigy 2 to other portable devices is that it has a simple headband to record forehead electroencephalogram to detect rapid eye movement (REM) and non-REM sleep stages. After processing Prodigy 2 signals, an apnea-hypopnea index (AHI) will be calculated for each participant based on the number of respiratory events (apneas or hypopneas) per hour of sleep. The investigators will measure AHI, REM AHI, non-REM AHI, AHI in different body postures, snoring duration, arousal index, sleep time with SpO2\<90%, oxygen desaturation index (ODI), and sleep efficiency.

Digital Technology is already approved in Canada, United States for the following indications:

Approved in Canada as Digital Diagnostic Tools for:

• Diagnosis of Sleep Apnea

Approved in United States as Telehealth Services for:

• Remote Monitoring of Sleep Disorders

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Recent advancements in technology have led to the development of various innovative diagnostic methods for sleep apnea, such as portable polygraphy and mattress-like devices, which are more accessible and comfortable compared to traditional polysomnography.

These new diagnostic tools are categorized based on their physical structure and sensing capabilities, highlighting their unique strengths and suitability for different applications, ultimately improving the experience for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Technologies for the Diagnosis of Sleep Apnea. Alshaer, H.[2019]

A review of 41 studies on digital tools for obstructive sleep apnea (OSA) screening found that some smartphone-based and wearable devices showed high accuracy, with the best performing tool achieving an area under the curve (AUC) of 0.99, sensitivity of 96%, and specificity of 92%.

Despite these promising results, most tools lack external validation against the gold standard of polysomnography, indicating a need for further quality studies before these digital tools can be reliably used in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Novel Digital Clinical Tools in the Screening or Diagnosis of Obstructive Sleep Apnea: Systematic Review. Duarte, M., Pereira-Rodrigues, P., Ferreira-Santos, D.[2023]

Telehealth interventions can significantly improve adherence to continuous positive airway pressure (CPAP) therapy for patients with moderate to severe obstructive sleep apnea (OSA), addressing a major challenge in treatment effectiveness.

The integration of telemonitoring and advanced technologies, such as artificial intelligence, into clinical practice is recommended to enhance patient care and support better health outcomes for OSA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Technology Application in Enhancing Continuous Positive Airway Pressure Adherence in Obstructive Sleep Apnea Patients: A Review of Current Evidence. Thong, BKS., Loh, GXY., Lim, JJ., et al.[2022]

Telemedicine is being effectively utilized for diagnosing sleep-disordered breathing, including obstructive sleep apnea, through home testing and remote monitoring, which enhances accessibility for patients.

The AILIFE system, developed in 1994, aims to improve treatment outcomes for obstructive sleep apnea by providing personalized lifestyle guidance via telecare, potentially increasing the effectiveness of various treatments like CPAP and surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Telemedicine and lifestyle modifications in obstructive sleep apnea patients]. Shiomi, T.[2011]

A study involving 21 adults with obstructive sleep apnea confirmed that a novel wireless method for transmitting CPAP compliance and usage data is 100% accurate when compared to traditional data collection methods.

This wireless technology not only reliably transmits compliance and efficacy data but also has the potential to improve patient monitoring and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless CPAP patient monitoring: accuracy study. Lankford, DA.[2019]

A new Wireless Blood Pulse-Oximeter System has been developed to allow sleep apnea patients to monitor their treatment efficacy at home, addressing the need for more consistent follow-up care.

This system enables patients to easily apply the device themselves and securely send data to healthcare providers, potentially improving the management of sleep apnea treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shortening the feedback loop for sleep apnea patients via a wireless blood pulse-oximetry system. Stepnowsky, C., Blair, P., DiNicola, G., et al.[2016]

The Appnea-Q mobile app was found to be a feasible and well-accepted tool for managing obstructive sleep apnea (OSA) among patients, with 72-88% of users willing to recommend it and 64.87% believing it could reduce hospital visits.

Healthcare professionals also recognized the app's usefulness for patient follow-up, especially in the early stages of CPAP therapy, indicating its potential to enhance remote monitoring and support for OSA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health application to support CPAP therapy in obstructive sleep apnoea: design, feasibility and perspectives. Suarez-Giron, M., Garmendia, O., Lugo, V., et al.[2022]

A novel at-home screening method for Obstructive Sleep Apnea (OSA) using a smartphone and a modified armband was developed and validated with 23 subjects, showing high sensitivity (92.3% to 100%) and accuracy (78.3% to 91.3%) for binary classifications of OSA severity.

This smartphone-based approach offers a promising alternative to the costly and time-consuming gold standard diagnostic procedure, Polysomnography (PSG), making OSA screening more accessible and efficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Apnea Screening System for at-home Recording and Analysis of Sleep Apnea Severity. Bonnesen, MP., Sorensen, HBD., Jennum, P.[2020]

The Xiaomi Mi Band 5 showed 78% accuracy in measuring sleep stages compared to polysomnography, with better performance in individuals without sleep disorders, indicating it may be useful for general sleep monitoring.

However, the device overestimated total sleep time and light sleep while underestimating wake after sleep onset and REM sleep, suggesting it may not be fully reliable for detailed sleep analysis, especially in those with sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Sleep Data Validation From the Xiaomi Mi Band 5 Against Polysomnography: Comparison Study. Concheiro-Moscoso, P., Groba, B., Alvarez-Estevez, D., et al.[2023]

In a study analyzing 65 safety events during polysomnography from January 2016 to January 2020, the rate of adverse events was found to be 1 in 147 studies, indicating a higher incidence than previously thought, especially in patients with multiple medical comorbidities.

The implementation of a formalized response protocol for sleep technicians significantly reduced the median response time to safety incidents to 3 minutes, highlighting the importance of training and preparedness in managing potential medical emergencies during sleep studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protocol for mitigating safety events in a sleep laboratory. Blattner, M., Dunham, K., Thomas, R., et al.[2022]

Obstructive Sleep Apnea (OSA) is a common sleep disorder primarily affecting adults and the elderly, with many patients remaining undiagnosed due to limitations in current diagnostic methods.

Smartphone platforms and mobile health (mHealth) systems are emerging as innovative solutions for diagnosing and managing OSA, as they can integrate essential sensors to monitor clinically relevant parameters effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth tools for monitoring Obstructive Sleep Apnea patients at home: Proof-of-concept. Camara, MA., Castillo, Y., Blanco-Almazan, D., et al.[2020]

eHealth interventions significantly improve CPAP adherence among adults with obstructive sleep apnea, increasing average nightly use by about 0.54 hours compared to usual care, based on a meta-analysis of 18 studies involving 5429 participants.

The effectiveness of eHealth strategies appears consistent regardless of whether they are used as an add-on to traditional care or as standalone solutions, but there is still uncertainty about the best types and durations of these interventions for long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth Interventions in Improving Treatment Adherence for Adults With Obstructive Sleep Apnea: Meta-Analytic Review. Aardoom, JJ., Loheide-Niesmann, L., Ossebaard, HC., et al.[2020]

Citations

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Auto-PAP Titration Efficacy in Obstructive Sleep Apnea According to the findings, using auto-PAP was associated with positive results in those with moderate and severe OSA.

2. cjrt.ca cjrt.ca/article/92080-positive-airway-pressure-therapy-adherence-and-outcomes-in-obstructive-sleep-apnea-an-exploratory-longitudinal-retrospective-randomized-chart-review

Positive airway pressure therapy adherence and outcomes ... Observational studies have found a significant reduction in mortality with four or more hours per night of PAP therapy compared to no usage9–12; ...

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Comparison between Automatic and Fixed Positive Airway ... During automatic therapy, patients reported more restful sleep, better quality sleep, less discomfort from pressure, and less trouble getting to sleep.

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Treatment of Adult Obstructive Sleep Apnea With Positive ... The data demonstrated that PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor ...

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Treatments for obstructive sleep apnea: CPAP and beyond In a review of the intervention, only 25% to 37% of patients had at least a 50% reduction in the AHI and a residual AHI of 10 or less, and a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5883394/

New technology to assess sleep apnea - PubMed Central - NIH Many new methods for recording sleep and diagnosing sleep disorders have been developed. Many sleep disorders are chronic conditions and require continuous ...

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FDA-cleared home sleep apnea testing devices The majority of FDA-cleared HSAT devices adhered to electrical safety and biocompatibility standards. Critical considerations encompass ...

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Novel devices and applications for diagnosing obstructive ... This article is intended to help readers become more informed about newer obstructive sleep apnea diagnostic devices and their underlying novel technologies.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11504067/

Telemedicine for obstructive sleep apnea syndrome Telemedicine (TM) is a new medical service model in which computer, communication, and medical technologies and equipment are used to provide “face-to-face” ...

10. jmir.org jmir.org/2023/1/e47735/

The Role of Novel Digital Clinical Tools in the Screening or ... This study aimed to identify, gather, and analyze the most accurate digital tools and smartphone-based health platforms used for OSA screening or diagnosis in ...