Exploring the Impact of a Sleep App on Sleep Quality in a General Population Sample: Pilot Randomized Controlled Trial
Authors: Armitage Bianca Tanya , Potts Henry W W , Irwin Michael R , Fisher Abi 
Published: April 2024

Background
A third of adults in Western countries have impaired sleep quality. A possible solution involves distributing sleep aids through smartphone apps, but most empirical studies are limited to small pilot trials in distinct populations (eg, soldiers) or individuals with clinical sleep disorders; therefore, general population data are required. Furthermore, recent research shows that sleep app users desire a personalized approach, offering an individually tailored choice of techniques. One such aid is Peak Sleep, a smartphone app based on scientifically validated principles for improving sleep quality, such as mindfulness meditation and cognitive behavioral therapy.

Objective
We aimed to test the impact of the smartphone app Peak Sleep on sleep quality and collect user experience data to allow for future app development.

Methods
This was a 2-arm pilot randomized controlled trial. Participants were general population adults in the United Kingdom (aged ≥18 years) who were interested in improving their sleep quality and were not undergoing clinical treatment for sleep disorder or using sleep medication ≥1 per week. Participants were individually randomized to receive the intervention (3 months of app use) versus a no-treatment control. The intervention involved free access to Peak Sleep, an app that offered a choice of behavioral techniques to support better sleep (mindfulness, cognitive behavioral therapy, and acceptance commitment therapy). The primary outcome was sleep quality assessed using the Insomnia Severity Index at baseline and 1-, 2-, and 3-month follow-ups. Assessments were remote using web-based questionnaires. Objective sleep data collection using the Oura Ring (Ōura Health Oy) was planned; however, because the COVID-19 pandemic lockdowns began just after recruitment started, this plan could not be realized. Participant engagement with the app was assessed using the Digital Behavior Change Intervention Engagement Scale and qualitative telephone interviews with a subsample.

Results
A total of 101 participants were enrolled in the trial, and 21 (21%) were qualitatively interviewed. Sleep quality improved in both groups over time, with Insomnia Severity Index scores of the intervention group improving by a mean of 2.5 and the control group by a mean of 1.6 (between-group mean difference 0.9, 95% CI –2.0 to 3.8), with was no significant effect of group (P=.91). App users’ engagement was mixed, with qualitative interviews supporting the view of a polarized sample who either strongly liked or disliked the app.

Conclusions
In this trial, self-reported sleep improved over time in both intervention and control arms, with no impact by group, suggesting no effect of the sleep app. Qualitative data suggested polarized views on liking or not liking the app, features that people engaged with, and areas for improvement. Future work could involve developing the app features and then testing the app using objective measures of sleep in a larger sample.

Trial Registration
ClinicalTrials.gov NCT04487483; https://www.clinicaltrials.gov/study/NCT04487483