SleepNCT04487483
Exploring the Impact of a Sleep App on Sleep Quality
A study testing Sleep App in people with Sleep, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2020to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or above
- Own a smartphone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sleep
- Being tested
- Sleep App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep App | Experimental | 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. Receives: Behavioral: Sleep App |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported sleep quality
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.
Measured: Baseline/1 month/2 months/3 months
Secondary outcomes (3)
Change in self-reported sleep
Measured using the Consensus Sleep Diary.
Measured: Baseline/2 months
Engagement with the sleep app
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.
Measured: Once a week for 3 months
Telephone interview qualitative user data
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).
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start13 Feb 2020
- Primary completion17 Jun 2020
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a two-arm pilot RCT where participants are randomly assigned to either the intervention or control group.
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Abi Fisher, University College, London
- Investigators
- Abi Fisher, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487483
- Sponsor's protocol ID
- SleepAppEvaluation
- Status last verified
- Aug 2020
- First submitted
- 7 Jul 2020
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot study and the investigators plan to disseminate findings in a peer reviewed publication and a masters thesis.
Publications
Armitage BT, Potts HWW, Irwin MR, Fisher A. Exploring the Impact of a Sleep App on Sleep Quality in a General Population Sample: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Aug 13;8:e39554. doi: 10.2196/39554.
PubMed 39137016
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of a Sleep App on Sleep Quality: a Randomised Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04487483
- Acronym / sponsor ID
- SleepAppEvaluation
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a two-arm pilot RCT where participants are randomly assigned to either the intervention or control group.
| Arm | Type | Receives |
|---|---|---|
| Sleep App | Experimental | Behavioral: Sleep AppParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 or above
- Own a smartphone
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep AppA 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. | Behavioural | Sleep App |
Primary outcome
Change in self-reported sleep quality
Time frame: Baseline/1 month/2 months/3 months
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.
3 secondary outcomes
Change in self-reported sleep
Time frame: Baseline/2 months
Engagement with the sleep app
Time frame: Once a week for 3 months
Telephone interview qualitative user data
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Derived from this study: PubMed 39137016Armitage BT, Potts HWW, Irwin MR, Fisher A. Exploring the Impact of a Sleep App on Sleep Quality in a General Population Sample: Pilot Randomized Controlled Trial. JMIR Form Res. 2024 Aug 13;8:e39554. doi: 10.2196/39554.
- Individual participant dataSharing planned: No. Pilot study and the investigators plan to disseminate findings in a peer reviewed publication and a masters thesis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abi Fisher principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep App in people with Sleep, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported sleep quality (time frame: Baseline/1 month/2 months/3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020; AzTrials last refreshed its copy on 6 Nov 2026.