A Behavioural Sleep Intervention for People With Mild Cognitive Impairment and Mild Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
This is two arm pilot randomized controlled trial, with the intervention gorup receiving AI-supported behavioral sleep intervention and control group receiving usual care
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of mild cognitive impairment or dementia with the global deterioration scale (GDS) score at 4 or lower; endorse one or more sleep problems; experience sleep issues an average of 3 or more nights per week over the past month; reachable by phone; ability to provide informed consent and willingness to participate in the study.
Disqualifiers
have a prior diagnosis of a primary sleep disorder (e.g., sleep apnoea); have a severe chronic illness that may cause sleep problems (e.g., emphysema); currently receiving medical, psychological, or psychiatric treatment for sleep disturbance or depression; severe visual or hearing impairment; uncontrolled medical conditions that may interfere with participation.
Trial design
Design model
Parallel
Treatments tested in this trial
AI-supported behavioral sleep intervention
BehavioralParticipants will receive 6 weekly sessions of group education and daily use of the AI sleep companion
control group
Other interventionUsual care
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Sleep disturbance
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Time frame
Baseline, immediately post-intervention (6 weeks)Secondary outcomes
1
Dysfunctional beliefs and attitudes about sleep
The Dysfunctional Beliefs and Attitudes about Sleep scale will be used
Time frame
Baseline and immediately post-intervention2
Emotional distress
will be measured with the Depression, Anxiety, and Stress-21 Scale
Time frame
Baseline and immediately post-intervention3
Cognitive function
Montreal Cognitive Assessment (MoCA) 5-min Hong Kong version will be used
Time frame
Baselin and immediately post-intervention4
Health related quality of life
EQ-5D will be used
Time frame
Baseline and immediately post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov