Clinical trial NCT05067569: App-delivered Sleep ThERapy for Older Individuals With Insomnia
Official title: App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: sleep
digital
older people
brief behavioural therapy
Lead sponsor: Woolcock Institute of Medical Research
Sponsor class: OTHER
Collaborators: name: University of Sydney
First posted: 2021-10-05
Enrollment: 270
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Older adults aged ≥ 60 years
2. Able to give informed online consent
3. Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
4. English fluency
5. Access to a smartphone and willingness/proficiency to use a mobile app

Exclusion Criteria:

1. Shift-workers
2. Travel to a destination with \>2 hours time-difference (within 30-days)
3. Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
4. Diagnosed sleep disorders other than insomnia
5. Regular sleep medications or sleep devices (\>2 times a week over last 6 months)
6. Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
7. Drive for work/operate heavy machinery

Primary outcomes:
measure: Change in insomnia symptom severity
timeFrame: Change score from baseline at 8 weeks
Secondary outcomes:
measure: Change in subjective sleep quality
timeFrame: Change score from baseline at 8 weeks
measure: Change in sleep onset latency
timeFrame: Change score from baseline at 8 weeks
measure: Change in wake after sleep onset
timeFrame: Change score from baseline at 8 weeks
measure: Change in total sleep time
timeFrame: Change score from baseline at 8 weeks
measure: Change in fatigue
timeFrame: Change score from baseline at 8 weeks
measure: Change in daytime sleepiness
timeFrame: Change score from baseline at 8 weeks
measure: Change in quality of Life
timeFrame: Change score from baseline at 8 weeks
measure: Change in depressive symptoms
timeFrame: Change score from baseline at 8 weeks
measure: Change in anxiety
timeFrame: Change score from baseline at 8 weeks
measure: Change in self-reported cognition
timeFrame: Change score from baseline at 8 weeks
measure: Engagement
timeFrame: Baseline, week 8
measure: The effect of baseline digital health literacy on therapy efficacy
timeFrame: Baseline, week 8
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
Study officials:
affiliation: Woolcock Institute of Medical Research
name: Ronald Grunstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sydney
name: Christopher Gordon, PhD
role: PRINCIPAL_INVESTIGATOR
References: