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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34AT008923-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to evaluate the feasibility of conducting a future randomized control trial that will compare the efficacy of sleep behavioral interventions in a high-risk community including adapted sleep hygiene and yoga. The investigators will conduct a 40 person 12-week randomized control trial (RCT) in low-income housing population where half the participants will receive a community adapted sleep hygiene intervention (SH) and half will receive a community adapted sleep hygiene intervention and a yoga intervention. The investigators will evaluate the feasibility of recruiting from our target community, randomizing individuals to interventions delivered in community rooms with home-based practices, and delivering the targeted interventions with high adherence and fidelity.
Inadequate sleep is highly prevalent in low-socioeconomic status (SES) and minority groups and associated with multiple health problems. The root causes of inadequate sleep are often related to behavioral practices and stress, both of which may be favorably impacted using socio-contextually appropriate sleep hygiene recommendations and mind-body practices such as yoga. A preliminary RCT that will address the role of sleep behavioral interventions in a high-risk community will be conducted. This evidence is needed to guide mind-body therapies in low-SES communities in which such strategies are under-utilized to improve health.
The investigators have assembled a multidisciplinary team of experts in sleep medicine, complementary and integrative health, behavioral medicine, community engagement, social epidemiology, and clinical trials to conduct a planning study to adapt behavioral sleep interventions for residents in urban low-income housing and to evaluate their uptake and fidelity. The investigators have conducted qualitative formative evaluation work and conducted modified SH and Yoga pilot studies. In this phase, the investigators will deliver a 12-week trial testing the feasibility of (1) an adapted sleep hygiene intervention (SH) and (2) yoga + adapted sleep hygiene intervention SH+Y):
A. A Sleep Hygiene (SH) Intervention, addressing: beliefs and attitudes towards sleep; challenges for adhering to sleep hygiene recommendations given chaotic family routines, work schedules and bedroom conditions; strategies for overcoming barriers, and prioritization of recommendations most likely to be efficacious.
B. A Yoga (Y) Intervention: intervention intensity/duration and class format; tailored home-based recommendations for bedtime practice combining meditation, breathing and postures; tools to assess and enhance adherence; race/ethnicity concordance of the instructor and student; and use of peer yoga assistants.
The investigators aim to conduct a 40 person 12-week RCT of SH vs SH+Y to inform the design of a future large-scale RCT. The investigators will evaluate the feasibility of recruiting from our target community, randomizing individuals to interventions delivered in community rooms with home-based practices, and delivering the targeted interventions with high adherence and fidelity. The following will be evaluated:
The investigators will also assess the feasibility of collecting a range of baseline, outcome, process and mediator data and to generate data to support use of specific measures in a later trial, including patterns of missingness of data, distributions of data, correlations between outcomes, baseline factors and mediators, and evaluation of "dose-response" associations between time in intervention and sleep duration and efficiency.
Power analysis (sample size, evaluable subjects, etc.): The study is designed for feasibility and not powered to test the intervention effect. The SH+Y intervention will be considered as potentially efficacious if the estimates for the change scores (post-pre within and between group changes and their 95% confidence intervals) are consistent with clinically significant improvements in sleep duration (actigraphy sleep increases by > 30 minutes), sleep quality improves by > 0.3 standard deviations), or sleep hygiene (reduction in deviation in wake time relative to recommended wake time > 25%). The investigators will consider inclusion of specific measurements (mediators) in a future RCT based on: <10% missingness; correlation of change score or baseline score with outcomes of >.20; absence of redundancy with a simpler metric (r<.80).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep hygiene & Yoga (SH+Y) | Experimental | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment). |
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| Sleep hygiene (SH) | Active Comparator | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep hygiene intervention | Behavioral | The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Duration | Change in sleep duration from baseline to follow-up measure by actigraphs. We will conduct a repeated measures ANCOVA, modeling time, intervention group and a time*intervention interaction. We will explore change in stress, anxiety, depressive symptoms, mindfulness, and sleep hygiene score as potential explanatory variables. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Redline, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29122272 | Background | Spadola CE, Rottapel R, Khandpur N, Kontos E, Bertisch SM, Johnson DA, Quante M, Khalsa SBS, Saper RB, Redline S. Enhancing yoga participation: A qualitative investigation of barriers and facilitators to yoga among predominantly racial/ethnic minority, low-income adults. Complement Ther Clin Pract. 2017 Nov;29:97-104. doi: 10.1016/j.ctcp.2017.09.001. Epub 2017 Sep 4. |
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Sleep hygiene (SH) group sessions served as a run-in period for randomization. Participants were consented to participate in the research study (n=38) and then attended two SH group session. At the end of the second SH session, participants were randomized to the SH-arm or the sleep hygiene and yoga (SH+Y) arm (n=33).
From January-March 2018, participants were recruited from two affordable housing communities. Convenience and snowball sampling methods were employed. Study staff and community partners provided information to interested participants at community events and distributed flyers and postcards throughout the communities.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep Hygiene & Yoga (SH+Y) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment). Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. Yoga intervention: Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks). |
| FG001 | Sleep Hygiene (SH) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline population includes those who consented to participate in the study and were randomized to the SH arm or SH+Y arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep Hygiene & Yoga (SH+Y) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment). Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. Yoga intervention: Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Duration | Change in sleep duration from baseline to follow-up measure by actigraphs. We will conduct a repeated measures ANCOVA, modeling time, intervention group and a time*intervention interaction. We will explore change in stress, anxiety, depressive symptoms, mindfulness, and sleep hygiene score as potential explanatory variables. | The missing count is based on 21 participants having adequate quality actigraphy data at both baseline and endpoint | Posted | Mean | Standard Deviation | minutes/night | 12 weeks |
|
Five months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleep Hygiene & Yoga (SH+Y) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. After completing the SH sessions, they will receive 10 weeks of the yoga intervention (8 in-person yoga sessions and 2 weeks of yoga home practice maintenance assessment). Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. Yoga intervention: Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis (foot) | Infections and infestations | Systematic Assessment | Participant reported inflammation in foot. When to ER and was prescribed antibiotics (Clindamycin) for cellulitis. Participant had a follow-up visit with primary care provider. |
This study was a developmental pilot to test novel interventions in the community. At this stage, sample sizes were not developed to achieve power and statistically reliable results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Redline | Brigham and Women's Hospital | 617-732-5859 | SREDLINE@BWH.HARVARD.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2018 | Sep 9, 2019 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2018 | Sep 9, 2019 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000070263 | Sleep Hygiene |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Yoga intervention | Behavioral | Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks). |
|
| BG001 | Sleep Hygiene (SH) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Sleep Duration | The number analyzed in rows differs from overall due to missing count (not all participants were compliant or successful in wearing actigraphy) | Mean | Standard Deviation | minutes/night |
|
| OG001 | Sleep Hygiene (SH) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. |
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|
| 0 |
| 16 |
| 0 |
| 16 |
| 8 |
| 16 |
| EG001 | Sleep Hygiene (SH) | Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment. Sleep hygiene intervention: The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal. | 0 | 17 | 0 | 17 | 6 | 17 |
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| Mild rash (actigraph) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participants reported mild rash or irritation on wrist from wearing actigraph watch. |
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| Ear infection | Ear and labyrinth disorders | Systematic Assessment |
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| Back pain/spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment | short-term back or shoulder pain or spasm |
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| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Root canal infection | Infections and infestations | Systematic Assessment | Participant had a root canal followed by infection; received treatment. |
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| Arm and chest pain | Cardiac disorders | Systematic Assessment | Pain in arm, chest, or heart leading to emergency department visit. |
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| Scratched cornea | Eye disorders | Systematic Assessment | Scratched cornea and received antibiotics treatment |
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| Infection | Infections and infestations | Systematic Assessment | Reported abdominal abscess and associated infection; was actively seeking medical treatment. |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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