An interventional study of Digital cognitive behavioural therapy for insomnia in Dementia, Mild Cognitive Impairment and Insomnia, sponsored by University College Cork. Completed at 1 site in Ireland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by University College Cork · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the feasibility of conducting a definitive randomised controlled trial that will determine the effectiveness of a digital cognitive behavioural therapy for insomnia intervention (Sleepio) in improving sleep, psychosocial health and cognitive performance in people with Mild Cognitive Impairment or mild dementia and co-morbid sleep disturbance.
Sleep is essential to maintain good physical and mental health and plays a central role in many physiological functions. Nevertheless, insomnia is common with approximately one-third of all adults experiencing insomnia symptoms, increasing to 75% in those aged over 65 years. Two recent meta-analyses suggest that insomnia increases the risk of developing dementia.
Cognitive behavioural therapy for insomnia (CBT-I) is the first-line treatment recommended for insomnia and is supported by a large evidence base. Unfortunately, however, CBT-I is often difficult to access due to the shortage of trained therapists. Digital CBT-I (dCBT-I) provides a possible solution to overcome the barriers associated with accessing the traditional therapist-delivered model of CBT-I. There is good evidence regarding the effectiveness of dCBT-I, which has also recently been shown to be feasible and effective in older people. A small mixed-methods study involving 12 participants has demonstrated preliminary acceptability of dCBT-I among older people with Mild Cognitive Impairment (MCI).
Sleepio is a dCBT-I programme that is specifically recommended as first-line treatment for insomnia by the National Institute for Health and Care Excellence (NICE). Underlying algorithms organise the delivery of evidence-based cognitive and behavioural techniques in a manner tailored to each individual based on their responses to an initial sleep study questionnaire and subsequent sleep diary entries throughout the duration of the programme. The Sleepio programme consists of six sessions. The programme can be completed within a six-week period. However, the average time taken to complete the programme is 9-10 weeks.
The investigators aim to conduct a randomised controlled feasibility study of this NICE-recommended dCBT-I intervention in participants with MCI and mild dementia.
Study participants will be community-dwelling adults aged fifty years and older with insomnia and established MCI or mild dementia. All patients attending outpatient memory clinics affiliated with the Mercy University Hospital in Cork City in the south of Ireland will be screened for eligibility. Consecutive patients who meet eligibility criteria will be invited to participate in the study. Where possible, study partners, being close friends or family members of study participants, will be recruited to support participants throughout the study.
Fully informed written consent will be obtained from each participant prior to enrolling them in the study. All participants will be determined able to provide informed written consent as adjudged by a consultant physician in geriatric medicine. Consent will also be obtained from their respective study partners (caregivers/friends/family members) if available and willing to participate.
Participants will be randomised to intervention versus true wait-list control in a 1:1 ratio using a centrally administered, computer-generated randomisation scheme. The study co-ordinator will be unblinded to study group assignment in order to facilitate provision of training regarding use of the intervention to those participants allocated to the intervention group. Site investigators, data collectors and statisticians will remain blinded to study group allocation.
At baseline, upon enrolment in the study, all participants will undergo assessments of their sleep, psychosocial health, cognition and function. These assessments will be repeated at follow up after 10 weeks.
This randomised controlled feasibility study will analyse the feasibility, acceptability and preliminary efficacy of a dCBT-I intervention to improve sleep, psychosocial health and cognitive function in participants with MCI and mild dementia. If shown to be feasible, the results will inform the design of a future definitive randomised controlled trial of the intervention in this population.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 30 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Established Mild Cognitive Impairment (MCI) or mild dementia, diagnosed by a consultant physician specialised in cognitive disorders prior to enrolment in the study. Dementia will be defined using DSM-5 classification and staged according to the Reisberg FAST scale into early/mild stage (Stages 1-4). MCI will be defined using Petersen's criteria. To participate those with MCI/mild dementia must score:
Exclusion Criteria:
A change in the following medication within the three months prior to enrolment:
Participants allocated to the intervention group will be provided with access to Sleepio, a fully-automated digital cognitive behavioural therapy for insomnia programme designed to treat insomnia using a combination of evidence-based cognitive and behavioural techniques. Underlying algorithms organise the delivery of information, support, and advice in a manner tailored to each individual participant based on their responses to an initial sleep study questionnaire and subsequent sleep diary entries throughout the duration of the programme. The Sleepio programme consists of six sessions, each ranging from five-to twenty minutes in duration. After the first session, each subsequent session is 'unlocked' one week after delivery of the prior session. Accordingly, the programme can be completed within a six-week period. However, the average time taken to complete the programme is 9-10 weeks.
Other: Digital cognitive behavioural therapy for insomnia
Participants allocated to the control group will continue to receive 'treatment-as-usual' throughout the duration of the study period. They will be informed that they will be provided with access to the intervention at the end of the study period.
Sleepio is a digital cognitive behavioural therapy for insomnia programme designed to treat insomnia by relying on underlying algorithms to tailor delivery of evidence-based cognitive and behavioural techniques based on participants' responses to an initial sleep study questionnaire and subsequent sleep diary entries throughout the duration of the programme.
Participant Recruitment
The aim of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess recruitment of the target number of 30 eligible participants during the six-month study period.
Time frame: Six Month Study Period
Participant Retention
The purpose of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess retention of the target number of 70% of enrolled participants throughout the study period.
Time frame: Six Month Study Period
Participant Adherence
The purpose of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess whether participants allocated to the intervention group achieve the target of 66% adherence to the intervention, defined as completion of four out of the six sessions involved in the intervention programme.
Time frame: Six Month Study Period
Acceptability of the Intervention
The purpose of this study is to assess the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess the acceptability of the intervention among the study population using a bespoke questionnaire incorporating the System Usability Scale adapted for cognitive impairment (targeting \>70% participants allocated to the intervention group scoring \>70/100) and the Usability Metric for User Experience - Lite (UMUX -Lite). The System Usability Scale is a validated and commonly employed 10-item Likert-type scale that provides a global assessment of how user-friendly a system or product is perceived to be. The UMUX-Lite is a more condensed 2-item Likert-type scale that also measures user-satisfaction with a system or product.
Time frame: Six Month Study Period
Sleep - Insomnia Severity Index (ISI)
Changes in sleep will be assessed using the Insomnia Severity Index (ISI). The ISI is a validated 7-item instrument to assess self-reported insomnia severity over the previous two weeks. Scores range from 0-28, with scores greater than or equal to 8 indicating sub-threshold insomnia and scores greater than or equal to 15 indicating clinical insomnia.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Sleep - Sleep Condition Indicator (SCI)
Changes in sleep will be measured using the Sleep Condition Indicator (SCI). The SCI is an 8-item scale validated to assess insomnia based on DSM-5 criteria. Scores range from 0-32, with scores less than or equal to 16 indicating insomnia.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Psychosocial Health - Patient Health Questionnaire 8 (PHQ-8)
Changes in psychosocial health will be assessed using the Patient Health Questionnaire 8 (PHQ-8), a valid diagnostic and severity measure for depressive disorders.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Psychosocial Health - Generalised Anxiety Disorder 7 (GAD-7),
Changes in psychosocial health will be measured using the Generalised Anxiety Disorder 7 (GAD-7), a widely-used and validated measure for assessing generalised anxiety disorder.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Psychosocial Health - Euroqol EQ 5D Visual Analogue Scale
Changes in psychosocial health will be measured using the Euroqol EQ 5D Visual Analogue Scale, which records subjective assessment of health-related quality of life on a 100-point vertical visual analogue scale on which the endpoints are labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Psychosocial Health - Dementia Quality of Life Instrument (DEMQOL)
Changes in psychosocial health will be measured using the Dementia Quality of Life Instrument (DEMQOL), a validated 29-item measure for assessing self-reported quality of life in people with dementia.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - Mini-Mental State Examination (MMSE)
Changes in cognition and function will be measured using the Mini-Mental State Examination (MMSE), a widely used measure of cognitive impairment scored from 0-30 with higher scores indicating better cognition.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
Changes in cognition and function will be measured using the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog), a validated assessment of cognition involving 11 tasks and scores ranging from 0-70.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - Clinical Dementia Rating (CDR) scale
Changes in cognition and function will be measured using the Clinical Dementia Rating (CDR) scale, a commonly used clinician-rating scale of global symptom severity in dementia.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - Disability Assessment for Dementia (DAD)
Changes in cognition and function will be measured using the Disability Assessment for Dementia (DAD), a 40-item assessment of functional ability involving personal and instrumental activities of daily living in people with dementia.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - British Columbia Cognitive Complaints Inventory (BC-CCI)
Changes in cognition and function will be measured using the British Columbia Cognitive Complaints Inventory (BC-CCI), a brief 6-item assessment of self-reported cognitive difficulties involving concentration, memory, articulation, thinking and problem-solving over the previous seven days. Scores range from 0-18, with higher scores indicating greater perceived cognitive impairment.
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Plan to share: No
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University College Cork