An interventional study of Sleep Using Mentored Behavioral and Environmental Restructuring in Insomnia, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
The goal of this study is to test potential functional/psychosocial benefits of improved sleep using a program designed to teach nursing facility staff to improve sleep promoting strategies and environment for nursing home residents. Sleep disturbances are quite common in skilled nursing facilities and affect as many as 69% of residents while staff do not fully understand how to improve sleep without using medications. Medications for sleep are commonly used as first-line therapy for older adults but this is problematic because these medications can lead to greater problems with thinking, more frequent falls, and even worse sleep over time. In addition, poor sleep can lead to depressed mood, greater trouble with thinking and memory, worse pain, and greater need for help with daily activities.
This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.
Exclusion Criteria:
Sequence 1 (Facility 1/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 39 Month Sustainability.
Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
Sequence 2 (Facility 1/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 33 Month Sustainability
Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
Sequence 3 (Facility 2/Unit 2): Baseline, then 3 Month SLUMBER Intervention, then 27 Month Sustainability
Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
Sequence 4 (Facility 2/Unit 3): Baseline, then 3 Month SLUMBER Intervention, then 21 Month Sustainability
Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
Sequence 5 (Facility 2/Unit 4): Baseline, then 3 Month SLUMBER Intervention, then 15 Month Sustainability
Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
Sequence 6 (Facility 3/Unit 1): Baseline, then 3 Month SLUMBER Intervention, then 9 Month Sustainability
Behavioral: Sleep Using Mentored Behavioral and Environmental Restructuring
SLUMBER is a non-pharmacological intervention program, delivered by providing mentoring to facility staff who work directly with residents. SLUMBER focuses on detecting sleep-disruptive factors including: nighttime noise and patient behaviors associated with poor sleep quality; disruptions caused by nighttime caregiving; daytime inactivity; and limited light exposure. In this model, staff-delivered interventions to improve these factors improve sleep quality thereby creating opportunities to test the impact of improving sleep quality (measured by actigraphy) on mood (depression and anxiety), pain, cognitive function, functional ability, and observed activity levels.
Also known as: SLUMBER
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Time frame: Baseline
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Time frame: Post-Treatment (Month 6 Post-Baseline)
Sleep Efficiency (SE)
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
Time frame: Month 9 Post-Baseline
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Time frame: Baseline
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Time frame: Post-Treatment (Month 6 Post-Baseline)
Nighttime Total Awake Time
Data will be obtained from antigraphy analysis.
Time frame: Month 9 Post-Baseline
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Time frame: Baseline
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Time frame: Post-Treatment (Month 6 Post-Baseline)
Daytime Sleeping (Napping) Time
Wrist device / actigraphy will be used to measure sleep/wake time.
Time frame: Month 9 Post-Baseline
Score on Pittsburgh Sleep Quality Index (PSQI)
PSQI contains 19 self-rated questions. The 19 questions are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas.
Time frame: Month 9 Post-Baseline
Brief Anxiety and Depression Scale (BADS) Questionnaire Score
BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment
Time frame: Month 9 Post-Baseline
Score on Brief Cognitive Assessment Tool (BCAT)
BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living.
Time frame: Month 9 Post-Baseline
| Milestone | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 |
|---|---|---|---|---|---|---|
| Started | 18 | 20 | 9 | 10 | 15 | 20 |
| Completed | 18 | 17 | 9 | 9 | 13 | 14 |
| Not completed | 0 | 3 | 0 | 1 | 2 | 6 |
| Withdrew: Incomplete (participant did not complete all data items collected during study visit) | 0 | 1 | 0 | 1 | 0 | 5 |
| Withdrew: Refused | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Covid-incomplete (couldn't collect all subject data due to nursing home covid shutdown) | 0 | 0 | 0 | 0 | 0 | 1 |
| Milestone | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 |
|---|---|---|---|---|---|---|
| Started | 18 | 17 | 9 | 9 | 13 | 14 |
| Completed | 13 | 16 | 6 | 8 | 11 | 0 |
| Not completed | 5 | 1 | 3 | 1 | 2 | 14 |
| Withdrew: Incomplete (participant did not complete all data items collected during study visit) | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 1 | 0 | 1 | 0 |
| Withdrew: Left nursing home facility | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 1 | 1 | 1 | 0 |
| Withdrew: Covid-incomplete (couldn't collect all subject data due to nursing home covid shutdown) | 0 | 0 | 0 | 0 | 0 | 14 |
| Milestone | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 |
|---|---|---|---|---|---|---|
| Started | 13 | 16 | 6 | 8 | 11 | 0 |
| Completed | 9 | 14 | 5 | 5 | 6 | 0 |
| Not completed | 4 | 2 | 1 | 3 | 5 | 0 |
| Withdrew: Incomplete (participant did not complete all data items collected during study visit) | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Left nursing home facility | 2 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 1 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Covid-incomplete (couldn't collect all subject data due to nursing home covid shutdown) | 0 | 0 | 0 | 3 | 5 | 0 |
| Milestone | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 |
|---|---|---|---|---|---|---|
| Started | 9 | 14 | 2 | 0 | 0 | 0 |
| Completed | 7 | 14 | 2 | 0 | 0 | 0 |
| Not completed | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Left nursing home | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 0 | 0 |
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
| percentage of time in bed | Resident of the Skilled Nursing Facility |
|---|---|
| Sleep Efficiency (SE) | 76.1 (71.83 to 80.38) |
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
| percentage of time in bed | Resident of the Skilled Nursing Facility |
|---|---|
| Sleep Efficiency (SE) | 75.69 (70.89 to 80.49) |
Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.
| percentage of time in bed | Resident of the Skilled Nursing Facility |
|---|---|
| Sleep Efficiency (SE) | 75.61 (70.05 to 81.18) |
Data will be obtained from antigraphy analysis.
| Minutes | Resident of the Skilled Nursing Facility |
|---|---|
| Nighttime Total Awake Time | 11.54 (9.92 to 13.15) |
Data will be obtained from antigraphy analysis.
| Minutes | Resident of the Skilled Nursing Facility |
|---|---|
| Nighttime Total Awake Time | 11.03 (9.22 to 12.84) |
Data will be obtained from antigraphy analysis.
| Minutes | Resident of the Skilled Nursing Facility |
|---|---|
| Nighttime Total Awake Time | 11.8 (9.29 to 14.31) |
Wrist device / actigraphy will be used to measure sleep/wake time.
| Minutes | Resident of the Skilled Nursing Facility |
|---|---|
| Daytime Sleeping (Napping) Time | 305.91 (261.63 to 350.18) |
Wrist device / actigraphy will be used to measure sleep/wake time.
| Minutes | Resident of the Skilled Nursing Facility |
|---|---|
| Daytime Sleeping (Napping) Time | 369.7 (314.92 to 424.47) |
Wrist device / actigraphy will be used to measure sleep/wake time.
| Minutes | Resident of the Skilled Nursing Facility |
|---|---|
| Daytime Sleeping (Napping) Time | 338.26 (287.79 to 388.73) |
PSQI contains 19 self-rated questions. The 19 questions are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas.
| score on a scale | Resident of the Skilled Nursing Facility |
|---|---|
| Score on Pittsburgh Sleep Quality Index (PSQI) | 6.5 (5.54 to 7.52) |
BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment
| score on a scale | Resident of the Skilled Nursing Facility |
|---|---|
| Brief Anxiety and Depression Scale (BADS) Questionnaire Score | 5.15 (3.74 to 6.55) |
BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living.
| score on a scale | Resident of the Skilled Nursing Facility |
|---|---|
| Score on Brief Cognitive Assessment Tool (BCAT) | 28.33 (25.42 to 31.23) |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resident of the Skilled Nursing Facility | 9/110 (8.2%) | 0/110 (0%) | 0/110 (0%) |
| Age, Continuous(years) | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 | Total |
|---|---|---|---|---|---|---|---|
| Mean | 66 ± 8 | 66 ± 8 | 89 ± 7 | 92 ± 8 | 91 ± 5 | 75 ± 11 | 81 ± 14 |
| Sex: Female, Male(Participants) | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 | Total |
|---|---|---|---|---|---|---|---|
| Female | 9 | 11 | 4 | 8 | 9 | 11 | 52 |
| Male | 9 | 6 | 5 | 1 | 4 | 3 | 28 |
| Ethnicity (NIH/OMB)(Participants) | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 2 | 0 | 2 | 2 | 17 |
| Not Hispanic or Latino | 13 | 11 | 7 | 9 | 11 | 12 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 2 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 13 | 9 | 0 | 0 | 1 | 3 | 26 |
| White | 0 | 2 | 7 | 7 | 10 | 9 | 35 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 6 | 2 | 0 | 2 | 2 | 17 |
| Region of Enrollment(participants) | F1U1 | F1U2 | F2U2 | F2U3 | F2U4 | F3U1 | Total |
|---|---|---|---|---|---|---|---|
| United States | 18 | 17 | 9 | 9 | 13 | 14 | 80 |
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