OurSleepKit for Sleep Apnea

Recruiting at 1 trial location

Overseen By Jack Johnson, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Other sleep disorders, Bariatric surgery, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

360 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if a couple-focused mobile health intervention will improve the use of continuous positive airway pressure (CPAP), the primary treatment option for obstructive sleep apnea (OSA). Participants include newly diagnosed patients with OSA who are candidates for CPAP treatment and their partners. The couples will received supportive information and resources on their mobile devices before CPAP begins and continuing for 6 months into CPAP treatment. Their interaction with the resources is self-paced and the time sent engaging with the information is up to them. Participants will be asked to answer questions independently at five points: before CPAP, and after using CPAP for 1-week, 1-month, 3-months and 6-months. Those questions are about their experience of using CPAP, how the partner is involved in CPAP treatment, and symptoms and quality of life. At the end of the study, some couples may be contacted for a virtual discussion about your experience regarding study participation which lasts approximately 1 hour.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using CPAP for sleep apnea, so it's best to ask the trial coordinators for guidance.

What data supports the effectiveness of the treatment OurSleepKit for sleep apnea?

The research on OurSleepKit suggests that involving partners in the treatment process may improve adherence to positive airway pressure (PAP) therapy, which is crucial for managing sleep apnea. This approach is based on the idea that mutual engagement can enhance the effectiveness of PAP treatment, as seen in other studies focusing on improving adherence to similar therapies. ^{1 2 3 4 5}

How is the OurSleepKit treatment for sleep apnea different from other treatments?

OurSleepKit is unique because it is a couple-focused mobile health tool designed to improve adherence to positive airway pressure (PAP) treatment by involving both the patient and their partner, unlike traditional methods that focus solely on the individual with sleep apnea. ^{1 6 7 8 9}

Eligibility Criteria

This trial is for couples where one partner has been newly diagnosed with obstructive sleep apnea (OSA) and is a candidate for CPAP treatment. They must be willing to use a mobile health intervention, OurSleepKit, and engage with it before and during the first 6 months of CPAP therapy.

Inclusion Criteria

The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP

Both partners should have their own mobile devices with access to the internet

I am over 18, have sleep apnea, am a candidate for CPAP therapy, and have lived with my partner for at least a year.

Exclusion Criteria

Have a partner using CPAP

Are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results

Couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment

Participants receive supportive information and resources on their mobile devices before CPAP begins

Up to 1 week

Self-paced interaction with resources

Treatment

Participants use CPAP with the support of the OurSleepKit app for 6 months

6 months

5 virtual assessments at 1-week, 1-month, 3-months, and 6-months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• OurSleepKit

Trial Overview The study tests if OurSleepKit, a couple-focused mobile health tool, can help people stick to their CPAP therapy better. Couples will receive resources on their phones to support them through the initial stages of using CPAP.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

Couples in the intervention group will have exposure to the OurSleepKit app in addition to usual care.

Group II: Control group Active Control 1 Intervention

Couples in the control group will not have exposure to the OurSleepKit app during the trial. Patients will receive usual care.

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

Findings from Research

The OurSleepKit prototype, developed through interviews with OSA patients and their partners, aims to enhance adherence to positive airway pressure (PAP) treatment by engaging both individuals in the relationship, rather than focusing solely on the patient.

Key features of OurSleepKit include personalized assessments, a Coaching Board with supportive content, and timely prompts to encourage positive conversations, all of which showed high acceptability and engagement among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing OurSleepKit: A Couple-focused mHealth Tool to Support Adherence to Positive Airway Pressure Treatment. Ye, L., Arnold Mages, M., Jimison, HB., et al.[2023]

In a clinical trial involving 302 patients with Obstructive Sleep Apnoea (OSA), the SLEEP-GOAL criterion demonstrated a higher success rate (69.8%) compared to the traditional Sher criteria (66.2%), suggesting it may provide a more comprehensive assessment of treatment outcomes.

The study revealed that relying solely on the Apnoea Hypopnea Index (AHI) can misclassify treatment success, as many patients showed significant improvements in blood pressure and oxygen levels that would not be captured by AHI alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SLEEP-GOAL: A multicenter success criteria outcome study on 302 obstructive sleep apnoea (OSA) patients. Pang, KP., Baptista, PM., Olszewska, E., et al.[2021]

The author emphasizes the need for long-term outcome data to better understand the effectiveness of sleep apnea interventions, beyond just short-term follow-up results.

Current studies may not provide a complete picture of the benefits and risks associated with sleep apnea treatments, highlighting the importance of comprehensive data for informed clinical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it the time to expect long-term outcome data in addition to follow-up data for sleep apnea interventions? Hunasikatti, M.[2022]

A home-based approach for diagnosing and treating obstructive sleep apnea (OSA) using portable monitoring and autoPAP resulted in significantly higher CPAP usage (4.7 hours per night) compared to in-laboratory testing (3.7 hours per night) after 3 months.

Participants using the home-based method also showed 12.6% higher adherence rates (62.8%) compared to those in the lab setting (49.4%), indicating that home monitoring may enhance patient compliance without compromising treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multisite randomized trial of portable sleep studies and positive airway pressure autotitration versus laboratory-based polysomnography for the diagnosis and treatment of obstructive sleep apnea: the HomePAP study. Rosen, CL., Auckley, D., Benca, R., et al.[2022]

A quality improvement initiative for pediatric obstructive sleep apnea treatment using CPAP led to a significant increase in follow-up visits within 4 months, rising from 38.2% to 65.5%, and reduced the median time to first follow-up from 133 days to 56 days.

The percentage of patients receiving a post-initiation polysomnogram within 1 year increased to 71.1%, and there were notable reductions in emergency department visit lengths and hospitalizations after starting CPAP, indicating improved healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure care for pediatric obstructive sleep apnea: A long-term quality improvement initiative. Xanthopoulos, MS., Williamson, AA., Burlingame, CC., et al.[2022]

The BodyMedia's SenseWear™ Armband (BSA) device accurately estimates total sleep time (TST) in patients with obstructive sleep apnea (OSA), showing strong agreement with the gold standard polysomnography (PSG) in a study of 107 OSA patients and 30 matched controls.

BSA demonstrated perfect agreement across different levels of OSA severity and genders, indicating it can be a reliable tool for assessing sleep in OSA patients, potentially complementing portable sleep studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep estimation using BodyMedia's SenseWear™ armband in patients with obstructive sleep apnea. Sharif, MM., Bahammam, AS.[2022]

In a study of 12 patients with obstructive sleep apnea-hypopnea syndrome (OSAHS), nasal CPAP therapy showed partial improvement in waking EEG patterns after 3 months, indicating some restoration of normal brain activity during wakefulness.

After 6 months of CPAP treatment, patients reported a normalization of sleepiness, although increased beta activity suggested that they still had to exert significant effort to stay awake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure treatment on the subsequent EEG spectral power and sleepiness over sustained wakefulness in patients with obstructive sleep apnea-hypopnea syndrome. Grenèche, J., Krieger, J., Bertrand, F., et al.[2011]

Providing adults with obstructive sleep apnea access to their positive airway pressure (PAP) usage data significantly improved adherence to treatment over 3 months compared to usual care, with average daily use increasing from 4.7 hours to 5.9 and 6.3 hours in the groups with web access.

The addition of a financial incentive in the first week did not further enhance adherence, indicating that simply having access to usage data is a key factor in improving treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Access to Positive Airway Pressure Usage with or without an Initial Financial Incentive Improves Treatment Use in Patients with Obstructive Sleep Apnea. Kuna, ST., Shuttleworth, D., Chi, L., et al.[2022]

A smartphone application that guides users through daily upper airway exercises significantly reduced snoring rates in participants, with a 22% reduction compared to a 5.6% reduction in the control group after 8 weeks.

All bed partners of participants using the app reported improvements in snoring volume and frequency, indicating that the intervention not only benefited the snorers but also improved the sleep quality of those around them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial. Goswami, U., Black, A., Krohn, B., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Developing OurSleepKit: A Couple-focused mHealth Tool to Support Adherence to Positive Airway Pressure Treatment. [2023]

2. Malaysia pubmed.ncbi.nlm.nih.gov

SLEEP-GOAL: A multicenter success criteria outcome study on 302 obstructive sleep apnoea (OSA) patients. [2021]

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

Is it the time to expect long-term outcome data in addition to follow-up data for sleep apnea interventions? [2022]

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

A multisite randomized trial of portable sleep studies and positive airway pressure autotitration versus laboratory-based polysomnography for the diagnosis and treatment of obstructive sleep apnea: the HomePAP study. [2022]

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

Continuous positive airway pressure care for pediatric obstructive sleep apnea: A long-term quality improvement initiative. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Sleep estimation using BodyMedia's SenseWear™ armband in patients with obstructive sleep apnea. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of continuous positive airway pressure treatment on the subsequent EEG spectral power and sleepiness over sustained wakefulness in patients with obstructive sleep apnea-hypopnea syndrome. [2011]

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

Web-Based Access to Positive Airway Pressure Usage with or without an Initial Financial Incentive Improves Treatment Use in Patients with Obstructive Sleep Apnea. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial. [2021]