Sleep DisturbanceSLEEPMATENCT06250725
Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
A study testing Cognitive Behavioral Therapy for Insomnia in people with Sleep Disturbance and Dementia, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Dementia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 30 Jun 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment or
- Montreal Cognitive Assessment (MOCA) score between 12 and 24;
- Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale;
- Have an eligible caregiver;
- Be able to participate in the intervention sessions
- ≥18 years old, co-residing with persons living with cognitive impairment (PLwCI);
Show all 10Show fewer
- Regularly assist the care recipient with ≥1 of 7 basic activities of daily living or
- ≥1 of 7 Instrumental Activities of Daily Living for the past 6 months;
- Have difficulty falling asleep or difficulty staying asleep for the last three months or
- Have a Pittsburgh Sleep Quality Index (PSQI) of 5 or greater
Who cannot join
- PLwCI: Moderate to severe cognitive impairment
- Individuals who are not yet adults
- Pregnant women
- Prisoners
- Individuals who are not able to clearly understand English.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.
Read the detailed description
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to the earlier placement of the PLwD in nursing homes and increases the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons.
There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the research team aims to examine the 1) feasibility and 2) preliminary efficacy of 6-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. PLwD-caregiver dyads will participate in videoconferencing sessions. In addition, semi-structured interviews will take place to examine the acceptability and satisfaction with the intervention.
- Conditions
- Sleep Disturbance, Dementia
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- Persons living with dementia (PLwD), Caregivers, Cognitive Behavioral Therapy for Insomnia (CBTi)
- Medical subject headings
- Parasomnias, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBTi
The intervention protocol will include CBTi principles like stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. It will be done over 6 weeks with one session weekly via videoconference.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBTi) | Experimental | Participant dyads will receive CBTi via videoconferencing sessions Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Insomnia will be measured using the Insomnia Severity Index. The insomnia severity index ahs seven questions. The seven answers are added up to get a total score.
Total score categories:
0-7= No clinically significant insomnia 8-14= Subthreshold insomnia 15-21= Clinical insomnia (moderate severity) 22-28= Clinical insomnia (Severe)
Measured: Baseline, 1-week post-intervention, and 3 months post-intervention
Sleep Efficiency
Sleep Efficiency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Measured: Baseline, 1-week post-intervention, and 3 months post-intervention
Sleep Onset Latency
Sleep onset latency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Measured: Baseline, 1-week post-intervention, and 3 months post-intervention
Wake After Sleep Onset
Wake after sleep onset will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Measured: Baseline, 1-week post-intervention, and 3 months post-intervention
Adherence with Study Interventions (feasibility)
Feasibility of the interventions will be assessed with rates of adherence to the study components throughout the study participation.
Measured: weekly during the intervention period up to 3 months post-intervention
Satisfaction with intervention components
Satisfaction with the intervention components will be assessed with the study satisfaction measure questionnaire that has 16 questions type that uses an agree, disagree scale as a range of answer options that go from strongly agree to strongly disagree.
Measured: 1 week post-intervention
Secondary outcomes (2)
The Center for Epidemiologic Studies Depression scale
Depression will be measured using the Center for Epidemiologic Studies Depression scale. The Center for Epidemiologic Studies Depression Scale has 20 questions. The 20 answers are added up to get a total score between 0 and 60.
Total score categories:
16 or greater = Clinically significant depressive symptoms
Measured: Baseline, 1-week post-intervention, and 3 months post-intervention
the research and development (RAND) Medical Outcomes short form (SF)-36.
Quality of Life will be measured using the Research and Development (RAND) Medical Outcomes short form (SF)-36. The insomnia severity index has 36 questions, which have subscales that total 100. The lower the score, the more disability. The higher the score, the less disability; i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, 1-week post-intervention, and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Aug 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Glenna Brewster, Emory University
- Investigators
- Glenna Brewster, PhD, RN, FNP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250725
- Sponsor's protocol ID
- STUDY00006711
- Other IDs
- 5K23AG070378-03, 2025P009764
- Acronym
- SLEEPMATE
- Status last verified
- Oct 2026
- First submitted
- 1 Feb 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share the participants' research identification with instrument responses.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Enhancement for Older Adults Living With Memory Loss And Their Care Partners
- ClinicalTrials.gov ID
- NCT06250725
- Acronym / sponsor ID
- SLEEPMATE / STUDY00006711
- Conditions
- Sleep Disturbance, Dementia
- Keywords
- Persons living with dementia (PLwD), Caregivers, Cognitive Behavioral Therapy for Insomnia (CBTi)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 9 Feb 2024 (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 determine if a 6-week videoconference intervention to teach skills to improve sleep is practical, acceptable, and helpful to persons living with memory loss, cognitive impairment, and/or dementia and care partners, individually or together.
Detailed description
Disturbed sleep is stressful to persons living with dementia (PLwD) and their caregivers. It contributes to the earlier placement of the PLwD in nursing homes and increases the risk for many psychological and cognitive health issues and poor quality of life for both the PLwD and the caregivers. Given the potential harmful side effects of medications, non-medication alternatives, such as Cognitive Behavioral Therapy for Insomnia (CBTi), may be safer to improve disturbed sleep in this population. CBTi which includes stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring, is effective and has durable and sustained effects on sleep outcomes over the long term. CBTi has improved sleep disturbances in PLwD and their caregivers, separately. Since disturbed sleep in the PLwD-caregiver dyad is bidirectional and interdependent, targeting the pair as a unit for intervention has the potential to lead to improved sleep and health outcomes for both persons.
There is no current published research on CBTi when the PLwD and their caregivers receive the intervention at the same time; as a result, the research team aims to examine the 1) feasibility and 2) preliminary efficacy of 6-week CBTi intervention for community-dwelling PLwD and their caregivers who are both experiencing sleep disturbances. PLwD-caregiver dyads will participate in videoconferencing sessions. In addition, semi-structured interviews will take place to examine the acceptability and satisfaction with the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBTi) | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaParticipant dyads will receive CBTi via videoconferencing sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of Alzheimer's Disease and Related Dementias (ADRD), or caregiver-reported probable or possible cognitive impairment or
- Montreal Cognitive Assessment (MOCA) score between 12 and 24;
- Had ≥1 sleep problem ≥3x/week on the Neuropsychiatric Inventory (NPI)-Nighttime Behavior Subscale;
- Have an eligible caregiver;
- Be able to participate in the intervention sessions
Key exclusion criteria (5 listed)
- PLwCI: Moderate to severe cognitive impairment
- Individuals who are not yet adults
- Pregnant women
- Prisoners
- Individuals who are not able to clearly understand English.
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 |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaAlso: CBTiThe intervention protocol will include CBTi principles like stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring. It will be done over 6 weeks with one session weekly via videoconference. | Behavioural | Cognitive Behavioral Therapy for Insomnia (CBTi) |
Primary outcome
Insomnia Severity Index
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
Insomnia will be measured using the Insomnia Severity Index. The insomnia severity index ahs seven questions. The seven answers are added up to get a total score. Total score categories: 0-7= No clinically significant insomnia 8-14= Subthreshold insomnia 15-21= Clinical insomnia (moderate severity) 22-28= Clinical insomnia (Severe)
Sleep Efficiency
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
Sleep Efficiency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Sleep Onset Latency
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
Sleep onset latency will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Wake After Sleep Onset
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
Wake after sleep onset will be measured using sleep diaries and actigraphy. Actigraphy watches monitor sleep-wake cycles by recording activity patterns continuously. Participants will also complete a diary each morning that asks about their sleep-wake patterns.
Adherence with Study Interventions (feasibility)
Time frame: weekly during the intervention period up to 3 months post-intervention
Feasibility of the interventions will be assessed with rates of adherence to the study components throughout the study participation.
Satisfaction with intervention components
Time frame: 1 week post-intervention
Satisfaction with the intervention components will be assessed with the study satisfaction measure questionnaire that has 16 questions type that uses an agree, disagree scale as a range of answer options that go from strongly agree to strongly disagree.
2 secondary outcomes
The Center for Epidemiologic Studies Depression scale
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
the research and development (RAND) Medical Outcomes short form (SF)-36.
Time frame: Baseline, 1-week post-intervention, and 3 months post-intervention
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 9 Oct 2026.
- Individual participant dataSharing planned: Yes. The research team will share the participants' research identification with instrument responses.
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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.
Glenna Brewster, PhD, RN, FNP principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Sleep Disturbance and Dementia, run by Emory University at 1 site in United States.
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 10 inclusion and 5 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 9 Oct 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 United States. 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?
Insomnia Severity Index (time frame: Baseline, 1-week post-intervention, and 3 months post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.