NCT06989619

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Jan 2025Sep 2026

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

May 4, 2025

Last Update Submit

May 16, 2025

Conditions

AgingCognitive ImpairmentSleep

Keywords

Sleep healthHealthy lifestyleBehavioral intervention

Outcome Measures

Primary Outcomes (3)

  • Time it takes to recruit

    Time it takes to recruit participants into the study

    Baseline, 2-months, and 6-months

  • Sessions attended

    Average number of sessions the participants attend.

    Baseline, 2-months, and 6-months

  • Proportion of participants who complete the program

    Proportion of older adults who complete the program.

    Baseline, 2-months, and 6-months

Secondary Outcomes (3)

  • The score of the Pittsburgh Sleep Quality Index (PSQI)

    Baseline, 2-months, and 6-months

  • The Score of the Dementia Quality of Life (DEMQOL)

    Baseline, 2-months, and 6-months

  • The Score of the Montreal Cognitive Assessment (MoCA)

    Baseline, 2-months, and 6-months

Study Arms (1)

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.

Behavioral: Sleep health and mindfulness intervention

Interventions

Sleep health and mindfulness interventionBEHAVIORAL

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.

Sleep Health and Mindfulness Program for Older Adults

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults (age 55 years of age and above) residing in residential facilities.

You may not qualify if:

  • Severe cognitive impairment according to the Montreal Cognitive Assessment (MoCA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Rebecca Robbins, PhD

    PhD

    STUDY CHAIR

Central Study Contacts

Chidera Ejikeme

CONTACT

2039792338cejikeme@bwh.harvard.edu

Rebecca Robbins, PhD

CONTACT

2039792338rrobbins4@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 4, 2025

First Posted

May 25, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
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.
Access Criteria
Consistent with the Brigham and Women's Hospital data sharing guidelines

Locations

US(1)