Digital Sleep Therapy for Older Adults With Cognitive Impairment

NCT ID: NCT05173844

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2025-10-01

Brief Summary

This study aims to determine the efficacy of digital Behavioural Therapy for Insomnia (dBTi) compared to online sleep health education (control) at reducing insomnia symptom severity (Insomnia Severity Index: ISI) in older adults (50+ years) with subjective cognitive impairment from baseline compared to week 8.

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. Recent work shows that sleep plays a critical role in optimising brain function and sleep disturbance is highly prevalent in individuals with cognitive impairment.

The investigators will conduct a fully online study comparing 3-weeks of digital brief behavioural therapy for insomnia (dBBTi) (in addtiotion to an extra optional 3 weeks) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix mobile application 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, cognition ,sleep, fatigue, sleepiness , anxiety, depression, quality of life and digital health literacy. These will be repeated at follow-up at weeks 8, 16.

Conditions

Insomnia Type; Sleep Disorder; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

Participants will be instructed to use SleepFix mobile application for 3 weeks with an optional 3 weeks of additional therapy. Participants will complete daily sleep diary entries (which take less than 1 min) which are used to calculate the sleep window titration. SleepFix incorporates sleep restriction and stimulus control which have been shown to be the most powerful components of cognitive-behavioural therapy for insomnia - CBTi. It has been shown to produce rapid, clinically-meaningful insomnia symptom reduction in a shorter period of time compared with both face-to-face and digital CBTi. SleepFix does not require the user to complete modules and multiple components such as other digital CBTi programs (e.g. Sleepio). Further, it is personalised to the individual's current sleep patterns and requires minimal engagement compared to full CBTi.

Group Type: EXPERIMENTAL

SleepFix mobile application

Intervention Type: OTHER

Digital behavioural therapy (dBTi) mobile application SleepFix® is specifically designed to treat insomnia and has been shown to be engaging and clinically efficacious.

Control

Participants randomised to the control group will gain access to the first Sleep Health Education module immediately following completion of baseline questionnaires. There are 3 modules provided bi-weekly and the information in these modules is presented as a subdomain through the study website. 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SleepFix mobile application

Digital behavioural therapy (dBTi) mobile application SleepFix® is specifically designed to treat insomnia and has been shown to be engaging and clinically efficacious.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 50 years and older
• Insomnia Severity Index score ≥10
• Self-reported subjective cognitive impairment as defined as moderate subjective cognitive complaints (i.e. answers YES to have cognitive concerns OR thinking and memory skills are worse than same-age peers on the online screening)
• English speaking
• Access to a smartphone and willingness/proficiency to use a mobile app for healthcare
• Able to give informed online consent

Exclusion Criteria

• Neurological (e.g. Parkinson's, epilepsy) and major psychiatric disease (e.g. current major depression), dementia, history of cerebrovascular events (stroke, TIA); history of head injury with loss of consciousness > 30mins;
• Self-reported jetlag symptoms due to travel in the last 7 days;
• Current illicit substance use or alcohol intake suggestive of a hazardous or harmful pattern;
• Shift-work;
• Medical conditions with known effects on cognition and sleep (e.g. cancer with chemotherapy);
• Diagnosed obstructive sleep apnoea, or other sleep disorder including REM Sleep Behaviour Disorder, Restless Legs Syndrome or Narcolepsy.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Woolcock Institute of Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Gordon, PhD

Role: PRINCIPAL_INVESTIGATOR

Macquarie University

Locations

Woolcock Institute of Medical Research

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

X21-0434

Identifier Type: -

Identifier Source: org_study_id