- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04487483
Exploring the Impact of a Sleep App on Sleep Quality
August 7, 2020 updated by: Abi Fisher, University College, London
Exploring the Impact of a Sleep App on Sleep Quality: a Randomised Controlled Pilot Study
Sufficient sleep is crucial for good health, yet a third of UK adults have impaired sleep quality.
Therefore, there is urgent need for population-level sleep interventions.
However, many sleep interventions (such as Cognitive Behavioural Therapy for Insomnia) are resource intensive and not widely available.
Research demonstrates that smartphone interventions are an effective way to reach the wider population.
However, many commercially available smartphone sleep applications focus on one technique, and hence do not tailor to the diverse needs of individuals.
A new sleep app offers six different techniques, allowing individuals to shape their own journey to improved sleep quality.
The investigators aim to test the sleep app's efficacy and gather user experience data to allow app optimisation.
The study is a two-arm pilot randomised control trial (RCT).
After recruitment and screening, baseline measurements will be taken: subjective sleep quality data will be collected using the Insomnia Severity Index (ISI) and the Consensus Sleep Diary from all participants and objective accelerometry data via an Oura Ring (worn on finger for a week) on a subsample of participants.
Participants will then be randomised to the intervention or control.
Intervention participants will be given free use of the sleep app for 3 months.
Controls will be informed that they will not receive access to the intervention and will be asked to abstain from using any other digital sleep-based intervention during the 3 months.
All participants will be given the ISI after each month and will be given the Consensus Sleep Diary to fill out for one week again after 2 months.
The planned Oura ring follow-up after 2 months for participants who wore the Oura ring at baseline has been cancelled due to COVID-19.
User engagement will be assessed using the Digital Behaviour Change Intervention Engagement Scale.
Telephone interviews will also be conducted with 20-30 participants to explore experience of using the app, how the comparison group felt about being allocated to the control group and how the COVID-19 pandemic may have affected their sleep and other measures of the study.
Change in self-reported sleep will be the primary outcome and qualitative user data secondary.
Appropriate tests (such as an ANOVA or linear regression controlling for baseline sleep and testing for effect of group when using continuous data) and thematic analysis of qualitative interview data will be conducted.
Study Overview
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom, WC1E 7HB
- University College London
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 or above
- Own a smartphone
Exclusion Criteria:
- Having a clinically diagnosed sleep disorder for which they are currently being treated
- Frequent use (once a week or more) of any sleep medication
- Enrolment on another sleep trial
- Being unwilling to cease usage of other sleep apps for the duration of the study
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sleep App
Participants in this condition will receive full free access to the "Pro" version of the sleep app and asked to use the app every day for three months.
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A sleep app offering 6 evidence based techniques to improve sleep (such as Cognitive Behavioural Therapy for Insomnia, Progressive Muscle Relaxation and Mindfulness Meditation), allowing for a personally tailored journey of sleep aids within the app.
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No Intervention: Control
Participants in this condition will be asked to continue their life as normal and abstain from downloading or using any sleep aid and/or sleep tracker app for three months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported sleep quality
Time Frame: Baseline/1 month/2 months/3 months
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Measured using the Insomnia Severity Index.
The scores from the Insomnia Severity Index range from 0 to 28, where higher scores indicate worse sleep quality.
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Baseline/1 month/2 months/3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported sleep
Time Frame: Baseline/2 months
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Measured using the Consensus Sleep Diary.
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Baseline/2 months
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Engagement with the sleep app
Time Frame: Once a week for 3 months
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Participant's responses to the Digital Behaviour Change Intervention Engagement Scale (only applicable to participants in the intervention group).
The scores from the Digital Behaviour Change Intervention Engagement Scale range from 8 to 56, where higher scores indicate higher engagement.
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Once a week for 3 months
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Telephone interview qualitative user data
Time Frame: Up to 6 months
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Participant's qualitative responses to telephone interview questions about their experience of using the sleep app, how the comparison group felt about being allocated to the control group, and how the COVID-19 pandemic may have affected their sleep and other measures of the study (on a subsample of 20-30 participants).
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Up to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Abi Fisher, University College, London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2020
Primary Completion (Actual)
June 17, 2020
Study Completion (Anticipated)
August 15, 2020
Study Registration Dates
First Submitted
July 7, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
August 7, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- SleepAppEvaluation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pilot study and the investigators plan to disseminate findings in a peer reviewed publication and a masters thesis.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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