Digital Sleep Therapy for Older Adults With Cognitive Impairment

NCT05173844 | Completed

• 1 other identifier: X21-0434
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Type; Sleep Disorder; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index

  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 (8)

• Change in self-reported cognitive impairment

  Change score from baseline at 8 weeks

• Change in sleep metrics and quality

  Change score from baseline at 8 weeks

• Change in depressive symptoms

  Change score from baseline at 8 weeks

• Change in anxiety symptoms

  Change score from baseline at 8 weeks

• Change in fatigue

  Change score from baseline at 8 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Other: SleepFix mobile application

Control

NO INTERVENTION

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.

Interventions

SleepFix mobile application OTHER

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

Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead

Study Sites (1)

Woolcock Institute of Medical Research

Sydney, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Christopher Gordon, PhD

  Macquarie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 30, 2021
• Study Start: November 10, 2022
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-06

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)