AgingNCT06989619
Leveraging Social Networks to Improve Sleep and Mindfulness Among Older Adults in Residential Housing Facilities
A study testing Sleep health and mindfulness intervention in people with Aging and Cognitive Impairment, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to design a sleep and mindfulness intervention to improve sleep, quality of life, and cognitive function among older adults. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Impairment, Sleep
- What is being tested?
- Sleep health and mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults (age 55 years of age and above) residing in residential facilities.
Who cannot join
- Severe cognitive impairment according to the Montreal Cognitive Assessment (MoCA).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Rebecca Robbins, PhD, 2039792338, rrobbins4@bwh.harvard.edu
About this study
The aim of this study is to design a sleep and mindfulness intervention to improve sleep, quality of life, and cognitive function among older adults.
Read the detailed description
The proposed R34 planning grant will the design and adapt a sleep, mindfulness, and sleep disorders education intervention entitled to cognitively unimpaired older adults residing in housing facilities. Novel, social network techniques will be used to identify opinion leaders who will assist with message dissemination. This grant will adapt content from an existing, evidence-based Sleep Health Program to the needs of older adults. In addition, the adapted Sleep Health Program will be coupled with Mindfulness content then disseminated in a small pilot study to ascertain feasibility and acceptability of the proposed novel social network approach for deploying the adapted Sleep Health and Mindfulness Program in a planned R01. The data collected in this R34 will include qualitative interview and usability interview data where cognitively unimpaired older adults will be recruited and asked to provide input to the messages and approach. Target outcomes will also be collected in the planned pilot, including survey responses to sleep, sleep disorders evaluation/care, quality of life, and cognition. Finally, FitBit data will also be captured for 2 weeks at several time points during the pilot study (baseline, 2-months, and 6-months).
- Conditions
- Aging, Cognitive Impairment, Sleep
- Being tested
- Sleep health and mindfulness intervention
- Keywords
- Sleep health, Healthy lifestyle, Behavioral intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep health and mindfulness interventionBehavioural
This educational, healthy lifestyle intervention will include several modules detailing sleep health and mindfulness strategies. In addition, opinion leaders will be identified in the population to help diffuse messages through each housing facility.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Health and Mindfulness Program for Older Adults | Experimental | This grant will develop and design an adapted version of an existing, effective Sleep Health Program, which will be coupled with mindfulness content, to meet the needs and unique barriers older adults in housing facilities face. The modules for the proposed Sleep Health and Mindfulness program will be designed in collaboration with the implementation partner, the City of Boston Age Strong Commission, whose talented leaders and staff have decades of experience designing programs for seniors on a variety of topics, including mindfulness. Receives: Behavioral: Sleep health and mindfulness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time it takes to recruit
Time it takes to recruit participants into the study
Measured: Baseline, 2-months, and 6-months
Sessions attended
Average number of sessions the participants attend.
Measured: Baseline, 2-months, and 6-months
Proportion of participants who complete the program
Proportion of older adults who complete the program.
Measured: Baseline, 2-months, and 6-months
Secondary outcomes (3)
The score of the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions which measures seven aspects of sleep: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. The 19 self-rated items are combined to form seven component scores, each of which has a range of 0-3 points (0 indicates no difficulty, while 3 indicates severe difficulty). The seven component scores are then summed to yield one global score, with a range of 0-21 points (0 indicating no difficulty, and 21 indicating severe difficulties in all the seven areas of sleep quality).
Measured: Baseline, 2-months, and 6-months
The Score of the Dementia Quality of Life (DEMQOL)
The Dementia Quality of Life (DEMQOL) instrument is a 28-item self-reported measure related to health-related quality-of-life (HRQL) in patients with dementia. The DEMQOL takes cognition, negative emotion, positive emotion, social relationships, and loneliness into consideration.
Measured: Baseline, 2-months, and 6-months
The Score of the Montreal Cognitive Assessment (MoCA)
The MoCA (Montreal Cognitive Assessment) test is scored out of 30 points, and a score of 26 or above is generally considered normal. A score of 26 or below may indicate some degree of cognitive impairment. The specific cutoff score for determining impairment is 26.
Measured: Baseline, 2-months, and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Rebecca Robbins, Brigham and Women's Hospital
- Investigators
- Rebecca Robbins, PhD, Study chair, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989619
- Sponsor's protocol ID
- BrighamHopsital
- Other IDs
- R34AG089176
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected in this R34 will be fully anonymous. Data and metadata will be made available through the NIH-funded National Sleep Research Resource (NSRR; www.SleepData.org). Data and metadata will be assigned a unique Digital Object Identifier (DOI) and a formal study citation by the repository (NSRR). All de-identified data will be shared by end of project period or time of publication, whichever is sooner, and will remain available indefinitely. We estimate data will be shared no later than year 2 of this R34 planning grant.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Social Networks to Improve Sleep and Mindfulness Among Older Adults in Residential Housing Facilities
- ClinicalTrials.gov ID
- NCT06989619
- Acronym / sponsor ID
- BrighamHopsital
- Conditions
- Aging, Cognitive Impairment, Sleep
- Keywords
- Sleep health, Healthy lifestyle, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 25 May 2025 (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 aim of this study is to design a sleep and mindfulness intervention to improve sleep, quality of life, and cognitive function among older adults.
Detailed description
The proposed R34 planning grant will the design and adapt a sleep, mindfulness, and sleep disorders education intervention entitled to cognitively unimpaired older adults residing in housing facilities. Novel, social network techniques will be used to identify opinion leaders who will assist with message dissemination. This grant will adapt content from an existing, evidence-based Sleep Health Program to the needs of older adults. In addition, the adapted Sleep Health Program will be coupled with Mindfulness content then disseminated in a small pilot study to ascertain feasibility and acceptability of the proposed novel social network approach for deploying the adapted Sleep Health and Mindfulness Program in a planned R01. The data collected in this R34 will include qualitative interview and usability interview data where cognitively unimpaired older adults will be recruited and asked to provide input to the messages and approach. Target outcomes will also be collected in the planned pilot, including survey responses to sleep, sleep disorders evaluation/care, quality of life, and cognition. Finally, FitBit data will also be captured for 2 weeks at several time points during the pilot study (baseline, 2-months, and 6-months).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep Health and Mindfulness Program for Older Adults | Experimental | Behavioral: Sleep health and mindfulness interventionThis grant will develop and design an adapted version of an existing, effective Sleep Health Program, which will be coupled with mindfulness content, to meet the needs and unique barriers older adults in housing facilities face. The modules for the proposed Sleep Health and Mindfulness program will be designed in collaboration with the implementation partner, the City of Boston Age Strong Commission, whose talented leaders and staff have decades of experience designing programs for seniors on a variety of topics, including mindfulness. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older adults (age 55 years of age and above) residing in residential facilities.
Key exclusion criteria (1 listed)
- Severe cognitive impairment according to the Montreal Cognitive Assessment (MoCA).
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 |
|---|---|---|
| Sleep health and mindfulness interventionThis educational, healthy lifestyle intervention will include several modules detailing sleep health and mindfulness strategies. In addition, opinion leaders will be identified in the population to help diffuse messages through each housing facility. | Behavioural | Sleep Health and Mindfulness Program for Older Adults |
Primary outcome
Time it takes to recruit
Time frame: Baseline, 2-months, and 6-months
Time it takes to recruit participants into the study
Sessions attended
Time frame: Baseline, 2-months, and 6-months
Average number of sessions the participants attend.
Proportion of participants who complete the program
Time frame: Baseline, 2-months, and 6-months
Proportion of older adults who complete the program.
3 secondary outcomes
The score of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 2-months, and 6-months
The Score of the Dementia Quality of Life (DEMQOL)
Time frame: Baseline, 2-months, and 6-months
The Score of the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 2-months, and 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Yes. All data collected in this R34 will be fully anonymous. Data and metadata will be made available through the NIH-funded National Sleep Research Resource (NSRR; www.SleepData.org). Data and metadata will be assigned a unique Digital Object Identifier (DOI) and a formal study citation by the repository (NSRR). All de-identified data will be shared by end of project period or time of publication, whichever is sooner, and will remain available indefinitely. We estimate data will be shared no later than year 2 of this R34 planning grant.
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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.
Rebecca Robbins, PhD study chair
PhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep health and mindfulness intervention in people with Aging and Cognitive Impairment, run by Brigham and Women's Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 25 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chidera Ejikeme (2039792338, cejikeme@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time it takes to recruit (time frame: Baseline, 2-months, and 6-months). The study lists 3 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 25 May 2025.