Trial Outcomes & Findings for Enhancing Sleep Quality for Nursing Home Residents With Dementia (NCT NCT04533815)

NCT ID: NCT04533815

Last Updated: 2024-01-10

Results Overview

Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 23 participants
• Primary outcome timeframe: 15 week sleep intervention period
• Results posted on: 2024-01-10

Participant Flow

Participants were recruited from the three participating community nursing homes. Nursing home staff referred residents to the study that they identified as meeting eligibility criteria.

Participant milestones

Measure	LOCK Sleep Intervention Nursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep intervention LOCK sleep intervention: Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling
Overall Study STARTED	23
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	LOCK Sleep Intervention Nursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep intervention LOCK sleep intervention: Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling
Overall Study Adverse Event	2
Overall Study Site withdrew	5

Baseline Characteristics

Enhancing Sleep Quality for Nursing Home Residents With Dementia

Baseline characteristics by cohort

Measure	LOCK Sleep Intervention n=23 Participants Nursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep intervention LOCK sleep intervention: Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling
Age, Continuous	77.74 Years STANDARD_DEVIATION 12.18 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Nighttime sleep minutes (actiwatch measurement)	520.00 Nighttime Sleep Minutes STANDARD_DEVIATION 113.30 • n=5 Participants

PRIMARY outcome

Timeframe: 15 week sleep intervention period

Population: Enrollees completing the 15-week intervention period

Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)

Outcome measures

Measure	LOCK Sleep Intervention n=16 Participants Nursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep intervention LOCK sleep intervention: Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling
Sleep (Actigraph Measurement)	544.00 Nighttime sleep minutes Standard Deviation 113.97

Adverse Events

LOCK Sleep Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LOCK Sleep Intervention n=23 participants at risk Nursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep intervention LOCK sleep intervention: Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling
Social circumstances Did not tolerate wearing actiwatch	8.7% 2/23 • Number of events 23 • During the active 15-week intervention period for each enrolled resident.

Additional Information

Dr. Lynn Snow

University of Alabama

Phone: 205-201-0312

Email: LSNOW@ua.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place