DementiaRESTNCT07363928
A Digital Cognitive Behavioural Therapy for Insomnia Intervention in Mild Cognitive Impairment and Mild Dementia
A study testing Digital cognitive behavioural therapy for insomnia in people with Dementia and Mild Cognitive Impairment, run by University College Cork at 1 site in Ireland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia, Mild Cognitive Impairment, Insomnia
- What is being tested?
- Digital cognitive behavioural therapy for insomnia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jan 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 years.
- Sleep Condition Indicator Score ≤16/32.
- 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:
- ≥18 on the Mini-Mental State Examination (MMSE), and
- ≥0.5-1.0 on the Clinical Dementia Rating (CDR) scale.
- Internet access for the duration of the intervention (via computer/tablet/smartphone).
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- Sufficient physical/sensory (visual/hearing) capacity to use the intervention, as judged by the clinician/investigator.
- English-speaker (intervention only available in English).
- Community-dwellers (non-institutionalised).
Who cannot join
- Known history of an International Classification of Diseases (ICD) defined sleep disorder other than insomnia disorder.
- Receipt of a sleep-related cognitive behavioural therapy (CBT) intervention within the past six months.
- MMSE score <18 at enrolment, to facilitate adherence and ensure recruitment of those with mild-stage disease.
- Severe depression (defined as depression requiring hospitalisation in the past 12-months or visit to psychiatry outpatient clinic in the past 3 months).
- Unstable depression/anxiety disorders or panic attacks (unstable will be defined as changes in antidepressant medications within the last 3 months, i.e. no start, stop or change in dose).
- Other relevant major neuropsychiatric disorders, including schizophrenia, psychosis, mania, bipolar affective disorder, epilepsy or seizure disorder.
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- Ongoing substance or alcohol abuse.
- Long-term physical or sensory impairment, pain or other medical condition which, in the opinion of the principal investigator, could impair participation for reasons other than cognitive impairment.
- Planned surgery or hospitalisation during the study that could interfere with participation.
- Medical conditions rendering the patient too unwell to continue to participate in the study in the opinion of the principal investigator.
- A change in the following medication within the three months prior to enrolment:
- Benzodiazepine and non-benzodiazepine hypnotic or anxiolytics agents
- Cholinesterase inhibitors or Memantine
- Antidepressants
- Antipsychotics
- Amphetamine derivatives
- Decongestants (pseudoephedrine, phenylephrine, phenyl¬propanolamine)
- Narcotic analgesics
- β-Blockers
- Pulmonary medications (theophylline and albuterol)
- Melatonin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Feasibility Study of a Digital Cognitive Behavioural Therapy for Insomnia Intervention in Mild Cognitive Impairment and Mild Dementia: The Randomised Evaluation of Sleep in Cognitive Impairment Trial
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.
Read the detailed description
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.
- Conditions
- Dementia, Mild Cognitive Impairment, Insomnia, Sleep
- Being tested
- Digital cognitive behavioural therapy for insomnia
- Keywords
- Digital cognitive behavioural therapy for insomnia, dementia, mild cognitive impairment, insomnia, sleep
- Medical subject headings
- Dementia, Cognitive Dysfunction, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital cognitive behavioural therapy for insomniaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Digital cognitive behavioural therapy for insomnia |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six Month Study Period
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (enrollment) and 10 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 2025
- Primary completion31 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- REST is an investigator-blinded, randomised, controlled, two arm, parallel, feasibility study. Participants will be randomised to intervention versus true wait-list control in a 1:1 ratio using a centrally administered, computer-generated randomisation scheme. An asymptotic maximal randomisation strategy, with a maximum tolerated imbalance of three, will be employed. Participants allocated to the intervention group will undertake the digital cognitive behavioural therapy programme (Sleepio). 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 assigned to the intervention group. Site investigators, data collectors and statisticians will remain blinded to study group assignment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rónán O'Caoimh, PhD, Principal investigator, Mercy University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363928
- Sponsor's protocol ID
- 24079
- Acronym
- REST
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tarnai K, Henry A, Miller C, Waxmonsky J, Emsley R, Espie C. 0352 Digital cognitive behavioral therapy in treating insomnia in older adulthood: A sub-analysis using individual participant data. Sleep. 2023;46(Supplement_1):A156-A.
Kyle SD, Hurry MED, Emsley R, Marsden A, Omlin X, Juss A, Spiegelhalder K, Bisdounis L, Luik AI, Espie CA, Sexton CE. The effects of digital cognitive behavioral therapy for insomnia on cognitive function: a randomized controlled trial. Sleep. 2020 Sep 14;43(9):zsaa034. doi: 10.1093/sleep/zsaa034.
PubMed 32128593Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.
PubMed 22654196Espie CA, Emsley R, Kyle SD, Gordon C, Drake CL, Siriwardena AN, Cape J, Ong JC, Sheaves B, Foster R, Freeman D, Costa-Font J, Marsden A, Luik AI. Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Jan 1;76(1):21-30. doi: 10.1001/jamapsychiatry.2018.2745.
PubMed 30264137Hoyos C, Espinosa N, Marshall N, LaMonica H, Gordon C, Rainey-Smith S, et al. 0441 Sleep Disturbance in MCI: A Pilot Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED). Sleep. 2024;47(Supplement_1):A189-A.
Mattos MK, Manning CA, Quigg M, Davis EM, Barnes L, Sollinger A, Eckstein M, Ritterband LM. Feasibility and Preliminary Efficacy of an Internet-Delivered Intervention for Insomnia in Individuals with Mild Cognitive Impairment. J Alzheimers Dis. 2021;84(4):1539-1550. doi: 10.3233/JAD-210657.
PubMed 34690141Lee Y, Kim I, Lee S, Yu S. Information and Communication Technology-Based Application for Cognitive Behavioral Therapy among Community-Dwelling Older Adults with Insomnia: Development and Validation Study. Healthcare (Basel). 2024 Jan 2;12(1):106. doi: 10.3390/healthcare12010106.
PubMed 38201011Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.
PubMed 26615572Soh HL, Ho RC, Ho CS, Tam WW. Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. Sleep Med. 2020 Nov;75:315-325. doi: 10.1016/j.sleep.2020.08.020. Epub 2020 Aug 26.
PubMed 32950013Koffel E, Kuhn E, Petsoulis N, Erbes CR, Anders S, Hoffman JE, Ruzek JI, Polusny MA. A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia. Health Informatics J. 2018 Mar;24(1):3-13. doi: 10.1177/1460458216656472. Epub 2016 Jun 27.
PubMed 27354394Naismith SL, Pye J, Terpening Z, Lewis S, Bartlett D. "Sleep Well, Think Well" Group Program for Mild Cognitive Impairment: A Randomized Controlled Pilot Study. Behav Sleep Med. 2019 Nov-Dec;17(6):778-789. doi: 10.1080/15402002.2018.1518223. Epub 2018 Sep 24.
PubMed 30247939Cassidy-Eagle E, Siebern A, Unti L, Glassman J, O'Hara R. Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. Clin Gerontol. 2018 Mar-Apr;41(2):136-144. doi: 10.1080/07317115.2017.1384777. Epub 2017 Dec 8.
PubMed 29220627Crowley P, O'Donovan MR, Leahy P, Flanagan E, O'Caoimh R. Pharmacological and Non-Pharmacological Interventions to Improve Sleep in People with Cognitive Impairment: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2025 Jun 18;22(6):956. doi: 10.3390/ijerph22060956.
PubMed 40566383Riemann D, Espie CA, Altena E, Arnardottir ES, Baglioni C, Bassetti CLA, Bastien C, Berzina N, Bjorvatn B, Dikeos D, Dolenc Groselj L, Ellis JG, Garcia-Borreguero D, Geoffroy PA, Gjerstad M, Goncalves M, Hertenstein E, Hoedlmoser K, Hion T, Holzinger B, Janku K, Jansson-Frojmark M, Jarnefelt H, Jernelov S, Jennum PJ, Khachatryan S, Krone L, Kyle SD, Lancee J, Leger D, Lupusor A, Marques DR, Nissen C, Palagini L, Paunio T, Perogamvros L, Pevernagie D, Schabus M, Shochat T, Szentkiralyi A, Van Someren E, van Straten A, Wichniak A, Verbraecken J, Spiegelhalder K. The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023. J Sleep Res. 2023 Dec;32(6):e14035. doi: 10.1111/jsr.14035.
PubMed 38016484Edinger JD, Arnedt JT, Bertisch SM, Carney CE, Harrington JJ, Lichstein KL, Sateia MJ, Troxel WM, Zhou ES, Kazmi U, Heald JL, Martin JL. Behavioral and psychological treatments for chronic insomnia disorder in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021 Feb 1;17(2):255-262. doi: 10.5664/jcsm.8986.
PubMed 33164742
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Feasibility Study of a Digital Cognitive Behavioural Therapy for Insomnia Intervention in Mild Cognitive Impairment and Mild Dementia: The Randomised Evaluation of Sleep in Cognitive Impairment Trial
- ClinicalTrials.gov ID
- NCT07363928
- Acronym / sponsor ID
- REST / 24079
- Conditions
- Dementia, Mild Cognitive Impairment, Insomnia, Sleep
- Keywords
- Digital cognitive behavioural therapy for insomnia, dementia, mild cognitive impairment, insomnia, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- REST is an investigator-blinded, randomised, controlled, two arm, parallel, feasibility study. Participants will be randomised to intervention versus true wait-list control in a 1:1 ratio using a centrally administered, computer-generated randomisation scheme. An asymptotic maximal randomisation strategy, with a maximum tolerated imbalance of three, will be employed. Participants allocated to the intervention group will undertake the digital cognitive behavioural therapy programme (Sleepio). 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 assigned to the intervention group. Site investigators, data collectors and statisticians will remain blinded to study group assignment.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Digital cognitive behavioural therapy for insomniaParticipants 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥50 years.
- Sleep Condition Indicator Score ≤16/32.
- 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:
- Internet access for the duration of the intervention (via computer/tablet/smartphone).
- Sufficient physical/sensory (visual/hearing) capacity to use the intervention, as judged by the clinician/investigator.
Key exclusion criteria (21 listed)
- Known history of an International Classification of Diseases (ICD) defined sleep disorder other than insomnia disorder.
- Receipt of a sleep-related cognitive behavioural therapy (CBT) intervention within the past six months.
- MMSE score <18 at enrolment, to facilitate adherence and ensure recruitment of those with mild-stage disease.
- Severe depression (defined as depression requiring hospitalisation in the past 12-months or visit to psychiatry outpatient clinic in the past 3 months).
- Unstable depression/anxiety disorders or panic attacks (unstable will be defined as changes in antidepressant medications within the last 3 months, i.e. no start, stop or change in dose).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital cognitive behavioural therapy for insomniaSleepio 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. | Other | Intervention Group |
Primary outcome
Participant Recruitment
Time frame: Six Month Study Period
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.
Participant Retention
Time frame: Six Month Study Period
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.
Participant Adherence
Time frame: Six Month Study Period
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.
Acceptability of the Intervention
Time frame: Six Month Study Period
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.
11 secondary outcomes
Sleep - Insomnia Severity Index (ISI)
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Sleep - Sleep Condition Indicator (SCI)
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Psychosocial Health - Patient Health Questionnaire 8 (PHQ-8)
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Psychosocial Health - Generalised Anxiety Disorder 7 (GAD-7),
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Psychosocial Health - Euroqol EQ 5D Visual Analogue Scale
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Psychosocial Health - Dementia Quality of Life Instrument (DEMQOL)
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - Mini-Mental State Examination (MMSE)
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - Clinical Dementia Rating (CDR) scale
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - Disability Assessment for Dementia (DAD)
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Cognition and Function - British Columbia Cognitive Complaints Inventory (BC-CCI)
Time frame: Baseline (enrollment) and 10 weeks post-enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- BackgroundTarnai K, Henry A, Miller C, Waxmonsky J, Emsley R, Espie C. 0352 Digital cognitive behavioral therapy in treating insomnia in older adulthood: A sub-analysis using individual participant data. Sleep. 2023;46(Supplement_1):A156-A.
- Background: PubMed 32128593Kyle SD, Hurry MED, Emsley R, Marsden A, Omlin X, Juss A, Spiegelhalder K, Bisdounis L, Luik AI, Espie CA, Sexton CE. The effects of digital cognitive behavioral therapy for insomnia on cognitive function: a randomized controlled trial. Sleep. 2020 Sep 14;43(9):zsaa034. doi: 10.1093/sleep/zsaa034.
- Background: PubMed 22654196Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.
- Background: PubMed 30264137Espie CA, Emsley R, Kyle SD, Gordon C, Drake CL, Siriwardena AN, Cape J, Ong JC, Sheaves B, Foster R, Freeman D, Costa-Font J, Marsden A, Luik AI. Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Jan 1;76(1):21-30. doi: 10.1001/jamapsychiatry.2018.2745.
- BackgroundHoyos C, Espinosa N, Marshall N, LaMonica H, Gordon C, Rainey-Smith S, et al. 0441 Sleep Disturbance in MCI: A Pilot Study of a Cognitive Behavioural Therapy Digital Intervention (SUCCEED). Sleep. 2024;47(Supplement_1):A189-A.
- Background: PubMed 34690141Mattos MK, Manning CA, Quigg M, Davis EM, Barnes L, Sollinger A, Eckstein M, Ritterband LM. Feasibility and Preliminary Efficacy of an Internet-Delivered Intervention for Insomnia in Individuals with Mild Cognitive Impairment. J Alzheimers Dis. 2021;84(4):1539-1550. doi: 10.3233/JAD-210657.
- Background: PubMed 38201011Lee Y, Kim I, Lee S, Yu S. Information and Communication Technology-Based Application for Cognitive Behavioral Therapy among Community-Dwelling Older Adults with Insomnia: Development and Validation Study. Healthcare (Basel). 2024 Jan 2;12(1):106. doi: 10.3390/healthcare12010106.
- Background: PubMed 26615572Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24.
- Background: PubMed 32950013Soh HL, Ho RC, Ho CS, Tam WW. Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. Sleep Med. 2020 Nov;75:315-325. doi: 10.1016/j.sleep.2020.08.020. Epub 2020 Aug 26.
- Background: PubMed 27354394Koffel E, Kuhn E, Petsoulis N, Erbes CR, Anders S, Hoffman JE, Ruzek JI, Polusny MA. A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia. Health Informatics J. 2018 Mar;24(1):3-13. doi: 10.1177/1460458216656472. Epub 2016 Jun 27.
- Background: PubMed 30247939Naismith SL, Pye J, Terpening Z, Lewis S, Bartlett D. "Sleep Well, Think Well" Group Program for Mild Cognitive Impairment: A Randomized Controlled Pilot Study. Behav Sleep Med. 2019 Nov-Dec;17(6):778-789. doi: 10.1080/15402002.2018.1518223. Epub 2018 Sep 24.
- Background: PubMed 29220627Cassidy-Eagle E, Siebern A, Unti L, Glassman J, O'Hara R. Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. Clin Gerontol. 2018 Mar-Apr;41(2):136-144. doi: 10.1080/07317115.2017.1384777. Epub 2017 Dec 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rónán O'Caoimh, PhD principal investigator
Mercy University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital cognitive behavioural therapy for insomnia in people with Dementia and Mild Cognitive Impairment, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment (time frame: Six Month Study Period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07363928, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.