InsomniaASTEROIDNCT05067569
App-delivered Sleep ThERapy for Older Individuals With Insomnia
A study testing SleepFix mobile application and Sleep Health Education in people with Insomnia, run by Woolcock Institute of Medical Research at 1 site in Australia.
Trial summary
This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- SleepFix mobile application and Sleep Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Oct 2022to 30 Apr 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults aged ≥ 60 years
- Able to give informed online consent
- Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
- English fluency
- Access to a smartphone and willingness/proficiency to use a mobile app
Who cannot join
- Shift-workers
- Travel to a destination with >2 hours time-difference (within 30-days)
- Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
- Diagnosed sleep disorders other than insomnia
- Regular sleep medications or sleep devices (>2 times a week over last 6 months)
- Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
- Drive for work/operate heavy machinery
Trial locations and contacts
1 site in 1 country.
Australia1 site
Woolcock Institute of Medical Research
Sydney, New South Wales, 2037
About this study
Official title: App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID Study)
This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.
Read the detailed description
Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population.
The investigators will conduct a fully online study comparing 6-weeks of digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Thereafter, participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix app delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module.
At baseline, all participants will complete self-reported measures of insomnia, sleep, fatigue, sleepiness , anxiety, depression, quality of life, cognition and digital health literacy. These will be repeated at follow-up at weeks 8, 16 and 26.
- Conditions
- Insomnia
- Being tested
- SleepFix mobile application, Sleep Health Education
- Keywords
- sleep, digital, older people, brief behavioural therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepFix mobile applicationBehavioural
The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.
Sleep Health EducationBehavioural
These internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet.
| Study group | Role | What they receive |
|---|---|---|
| Digital brief behavioural therapy for insomnia | Experimental | Participants randomised to the digital brief behavioural therapy for insomnia (SleepFix app) will be provided an unique access code to download the app. The intervention uses sleep retraining therapy to reduce excess time spent in bed and retrain sleep by matching time in bed (minimum of five and a half hours) to total sleep time. All participants in the intervention arm will also be provided a sleep-tracking wearable device (Fitbit) which will synchronised bed times (going to bed and rising) and are synchronised with the SleepFix app. Participants wil complete a daily sleep diary, rate sleep quality and mood. The intervention is provided for 6 weeks. Receives: Behavioral: SleepFix mobile application |
| Sleep Health Education wait-list control | Active comparator | Participants randomised to the control group will gain access to the first Sleep Health Education module immediately following completion of baseline questionnaires. There are three modules provided bi-weekly with information about sleep health and broad details about managing sleep disturbances. Participants will receive a link to this information as each module is made available.
Upon completion of the study (week 26), the control group will receive free access to the SleepFix mobile application. Receives: Behavioral: Sleep Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insomnia symptom severity
Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 4) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.
Measured: Change score from baseline at 8 weeks
Secondary outcomes (12)
Change in subjective sleep quality
Subjective sleep quality will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with seven component scores derived from the responses, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0-21) where a score of 5 or more indicates poor sleep quality.
Measured: Change score from baseline at 8 weeks
Change in sleep onset latency
Sleep onset latency will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess sleep onset latency over the last 2 weeks.
Measured: Change score from baseline at 8 weeks
Change in wake after sleep onset
Wake after sleep onset will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess wake after sleep onset over the last 2 weeks.
Measured: Change score from baseline at 8 weeks
Change in total sleep time
Total sleep time will be determined from the Pittsburgh Sleep Quality Index Score (PSQI) - a 19-item questionnaire with a total score range of 0 to 21 with scores greater than 5 indicating poor sleep quality. A single item will be used to assess total sleep time over the last 2 weeks.
Measured: Change score from baseline at 8 weeks
Change in fatigue
The Flinders Fatigue Scale (FFS) is a 7-item self-reported instrument designed to measure the level of subjective daytime fatigue experienced over the previous two weeks. 6-items consist of a 5-point Likert type scale ranging from "not at all" = 0 to "extremely" = 4. Item 5 uses a multiple-item checklist and is scored as a sum. All items are summed with total scores ranging from 0-31 with higher scores reflecting greater fatigue.
Measured: Change score from baseline at 8 weeks
Change in daytime sleepiness
The Epworth Sleepiness Scale (ESS) is an 8-item self-reported questionnaire that provides a rating of general sleepiness over the last 2 weeks using a 4-point likert scale from "would never dose" = 0 to "high chance of dozing" = 3. All items are summed with total scores ranging from 0-26 where scores >10 indicating above-average daytime sleepiness.
Measured: Change score from baseline at 8 weeks
Change in quality of Life
The EuroQol five-dimensional (EQ-5D) is a self-reported questionnaire which assesses 5 dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression and overall health. The 5 dimensions range from "1 = indicating no problem" - "5 = indicating unable to/extreme problems" and the overall score from 0 (worst health state imaginable) to 100 (best health state imaginable).
Measured: Change score from baseline at 8 weeks
Change in depressive symptoms
The Patient Health Questionnaire-9 is a 9-item self-reported measure of depressive symptoms over the past 2 weeks. Scores for each question (Likert type scale "not at all" = 0 to "nearly every day" = 3) sum to a total score out of 27 with higher scores reflecting severe depressive symptoms.
Measured: Change score from baseline at 8 weeks
Change in anxiety
The General Anxiety Disorder-7 (GAD-7) is a 7-item self-administered scale used to assess the severity of generalised anxiety over the previous 2 weeks. It consists of a three-point Likert type scale for each item (ranging from "not at all" = 0 to "nearly every day" = 3). All items are summed with total scores ranging from 0-21 where 5, 10 and 15 indicate the cut-off scores for mild, moderate and severe anxiety, respectively.
Measured: Change score from baseline at 8 weeks
Change in self-reported cognition
The British Columbia Cognitive Complaints Inventory (BC-CCI) is a 6-item tool to assess self-perceived cognition. It explores any perceived problems associated with cognition, memory, expressing thoughts, word finding, slow thinking, and difficulty solving problems in reflection of the last 7 days. Answers for each question range from 0 (= "not at all") to 3 (= "Very much"). Scores are summed to a total out of 18 that reflects the cognitive complaint severity.
Measured: Change score from baseline at 8 weeks
Engagement
To determine if there is a relationship between therapeutic outcome (Insomnia Severity Index, ISI) and engagement (number of in-app sleep diary entries for study completers)
Measured: Baseline, week 8
The effect of baseline digital health literacy on therapy efficacy
Digital health literacy will be assessed using the eHEALS Literacy Scale (eHEALS) which is an 8-item, 5-point Likert-type questionnaire that measures a participant's perception of, and ability toward electronic health information. Responses range from "strongly disagree" =1, to "strongly agree" = 5. Total scores are summed to range from 8 to 40 where lower scores indicate lower self-reported digital health literacy.
The moderating effect of the baseline digital health literacy on therapeutic outcomes (ISI scores) and engagement (number of daily sleep diary entries) will be assessed.
Measured: Baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Oct 2022
- Primary completion31 Jan 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be provided with a digital brief behavioural therapy (SleepFix app) which provides personalised sleep retraining therapy. Participants will also be provided a sleep-tracking wearable device (Fitbit) that synchronises the going to bed and getting out of bed times with the SleepFix app. Participants will complete a daily sleep diary and can modify the sleep-tracking wearable device sleep data. The program will provide an individualised sleep window of when to go and when to get out of bed. There are five stages focusing on bed timings, sleep efficiency and a maintenance phase for consolidating the new sleep pattern. The program provides information related to sleep hygiene and stimulus control. This will be available for participants for 6 weeks. An active wait-listed control of sleep health education will consist of 3 modules delivered biweekly of generalised sleep health information that could be found on the internet.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woolcock Institute of Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Sponsor
- Investigators
- Ronald Grunstein, MD, PhD, Principal investigator, Woolcock Institute of Medical ResearchChristopher Gordon, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067569
- Sponsor's protocol ID
- X21-0265
- Acronym
- ASTEROID
- Status last verified
- Jul 2025
- First submitted
- 8 Sep 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data may be made available upon the Principal investigator's agreement with an amendment required to the approving ethics board.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID Study)
- ClinicalTrials.gov ID
- NCT05067569
- Acronym / sponsor ID
- ASTEROID / X21-0265
- Conditions
- Insomnia
- Keywords
- sleep, digital, older people, brief behavioural therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Woolcock Institute of Medical ResearchUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 5 Oct 2021 (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.
This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.
Detailed description
Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population.
The investigators will conduct a fully online study comparing 6-weeks of digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Thereafter, participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix app delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module.
At baseline, all participants will complete self-reported measures of insomnia, sleep, fatigue, sleepiness , anxiety, depression, quality of life, cognition and digital health literacy. These will be repeated at follow-up at weeks 8, 16 and 26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be provided with a digital brief behavioural therapy (SleepFix app) which provides personalised sleep retraining therapy. Participants will also be provided a sleep-tracking wearable device (Fitbit) that synchronises the going to bed and getting out of bed times with the SleepFix app. Participants will complete a daily sleep diary and can modify the sleep-tracking wearable device sleep data. The program will provide an individualised sleep window of when to go and when to get out of bed. There are five stages focusing on bed timings, sleep efficiency and a maintenance phase for consolidating the new sleep pattern. The program provides information related to sleep hygiene and stimulus control. This will be available for participants for 6 weeks. An active wait-listed control of sleep health education will consist of 3 modules delivered biweekly of generalised sleep health information that could be found on the internet.
| Arm | Type | Receives |
|---|---|---|
| Digital brief behavioural therapy for insomnia | Experimental | Behavioral: SleepFix mobile applicationParticipants randomised to the digital brief behavioural therapy for insomnia (SleepFix app) will be provided an unique access code to download the app. The intervention uses sleep retraining therapy to reduce excess time spent in bed and retrain sleep by matching time in bed (minimum of five and a half hours) to total sleep time. All participants in the intervention arm will also be provided a sleep-tracking wearable device (Fitbit) which will synchronised bed times (going to bed and rising) and are synchronised with the SleepFix app. Participants wil complete a daily sleep diary, rate sleep quality and mood. The intervention is provided for 6 weeks. |
| Sleep Health Education wait-list control | Active comparator | Behavioral: Sleep Health EducationParticipants randomised to the control group will gain access to the first Sleep Health Education module immediately following completion of baseline questionnaires. There are three modules provided bi-weekly with information about sleep health and broad details about managing sleep disturbances. Participants will receive a link to this information as each module is made available. Upon completion of the study (week 26), the control group will receive free access to the SleepFix mobile application. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older adults aged ≥ 60 years
- Able to give informed online consent
- Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
- English fluency
- Access to a smartphone and willingness/proficiency to use a mobile app
Key exclusion criteria (7 listed)
- Shift-workers
- Travel to a destination with >2 hours time-difference (within 30-days)
- Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
- Diagnosed sleep disorders other than insomnia
- Regular sleep medications or sleep devices (>2 times a week over last 6 months)
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 |
|---|---|---|
| SleepFix mobile applicationThe SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults. | Behavioural | Digital brief behavioural therapy for insomnia |
| Sleep Health EducationThese internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet. | Behavioural | Sleep Health Education wait-list control |
Primary outcome
Change in insomnia symptom severity
Time frame: Change score from baseline at 8 weeks
Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 4) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.
12 secondary outcomes
Change in subjective sleep quality
Time frame: Change score from baseline at 8 weeks
Change in sleep onset latency
Time frame: Change score from baseline at 8 weeks
Change in wake after sleep onset
Time frame: Change score from baseline at 8 weeks
Change in total sleep time
Time frame: Change score from baseline at 8 weeks
Change in fatigue
Time frame: Change score from baseline at 8 weeks
Change in daytime sleepiness
Time frame: Change score from baseline at 8 weeks
Change in quality of Life
Time frame: Change score from baseline at 8 weeks
Change in depressive symptoms
Time frame: Change score from baseline at 8 weeks
Change in anxiety
Time frame: Change score from baseline at 8 weeks
Change in self-reported cognition
Time frame: Change score from baseline at 8 weeks
Engagement
Time frame: Baseline, week 8
The effect of baseline digital health literacy on therapy efficacy
Time frame: Baseline, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Woolcock Institute of Medical ResearchLink provided by the sponsor.
- Faculty of Medicine and Health, The University of SydneyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All de-identified data may be made available upon the Principal investigator's agreement with an amendment required to the approving ethics board.
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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.
Ronald Grunstein, MD, PhD principal investigator
Woolcock Institute of Medical Research
Christopher Gordon, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepFix mobile application and Sleep Health Education in people with Insomnia, run by Woolcock Institute of Medical Research at 1 site in Australia.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 22 Dec 2025. 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 Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 insomnia symptom severity (time frame: Change score from baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025.