App-delivered Sleep ThERapy for Older Individuals With Insomnia

NCT05067569 | Completed DMC

• 1 other identifier: X21-0265
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

sleep; digital; older people; brief behavioural therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Change score from baseline at 8 weeks

Secondary Outcomes (12)

• Change in subjective sleep quality

  Change score from baseline at 8 weeks

• Change in sleep onset latency

  Change score from baseline at 8 weeks

• Change in wake after sleep onset

  Change score from baseline at 8 weeks

• Change in total sleep time

  Change score from baseline at 8 weeks

• Change in fatigue

  Change score from baseline at 8 weeks

Study Arms (2)

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.

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.

Behavioral: Sleep Health Education

Interventions

SleepFix mobile application BEHAVIORAL

The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.

Digital brief behavioural therapy for insomnia

Sleep Health Education BEHAVIORAL

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.

Sleep Health Education wait-list control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sydney: collaborator
• Woolcock Institute of Medical Research: lead

Study Sites (1)

Woolcock Institute of Medical Research

Sydney, New South Wales, 2037, Australia

Location

Related Links

• Woolcock Institute of Medical Research
• Faculty of Medicine and Health, The University of Sydney

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Ronald Grunstein, MD, PhD

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

• Christopher Gordon, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants will not be blinded as they will know what treatment they receive. This is typical of behavioural interventions. Note: the study project coordinator will not be blinded as they will be managing the study such as sending sleep-tracking wearable devices to the intervention arm and communicating with participants. All investigators and data analysts will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 5, 2021
• Study Start: October 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The study data will be available following all analyses.
• Access Criteria: Contact the Coordinating Principal Investigator for access to data.

Locations

AU (1)