An interventional study of Sleep hygiene intervention and Yoga intervention in Sleep, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
Among 41 studies in Sleep Hygiene with a site in United States — 9 open to participants now, 11 under way, none of them phase 3. Sleep Hygiene · United States.
Among the 41 studies in Sleep Hygiene with a site in United States, this one is the 30th largest by enrollment of the 39 interventional ones that give a count, is one of 4 that started in 2018, is one of 36 with no phase, and was the 7th registered.
126 studies on the registry are indexed under Sleep Hygiene; 32 are open to participants now.
Browse Sleep Hygiene studies →9 of the 41 studies in Sleep Hygiene with a site in United States are open now. Recruiting first, the newest first:
University of Alabama at Birmingham · Sites in United States
Northern Arizona University · Sites in United States
University of Utah · Sites in United States
Farhaan S. Vahidy · Sites in United States
University of Utah · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 16 Sleep Hygiene studies recruiting now, 4 (25%) set no upper age limit and 11 (69%) stop at 75 or younger; 1 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
41 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 1
First in 2004; this study’s year is marked. 4 started in 2018.
This study's enrollment of 33 is below the median of 66 across 113 interventional studies indexed under Sleep Hygiene.
Median enrollment 64 across the 39 interventional studies, 62 across the 2 observational. Of the 27 that completed or were terminated, 5 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 41 have an industry lead sponsor. The 10 most frequent:
Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Brigham and Women's Hospital has 1 study filed under Sleep Hygiene — fewer than ten, so there is no comparison to draw.
4 of the studies in Sleep Hygiene with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07765849Northern Arizona UniversityOnline Sleep Education for College Student's Sleep Health and Executive Functioning | 2026-12 |
| NCT05943626University of UtahCircadian Intervention to Improve Cardiometabolic Health | 2026-12 |
| NCT07862348University of Alabama at BirminghamSleep Better, Live Better Study | 2027-07-31 |
| NCT05234125University of Illinois at ChicagoBetter Lifestyle Counseling for African American Women During Pregnancy | 2027-09-02 |
Among the 41 studies in Sleep Hygiene with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
Behavioral: Sleep hygiene intervention · Behavioral: Yoga intervention
Participants will receive the sleep hygiene intervention, which includes 2 sleep hygiene sessions and 10 weeks of maintenance assessment.
Behavioral: 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.
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).
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.
Time frame: 12 weeks
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.
| Milestone | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) |
|---|---|---|
| Started | 16 | 17 |
| Completed | 14 | 15 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Conflicts with personal schedule | 1 | 0 |
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.
| minutes/night | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) |
|---|---|---|
| Sleep Duration | -0.91 ± 43.87 | -2.93 ± 66.92 |
Collected over Five months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sleep Hygiene & Yoga (SH+Y) | 0/16 (0%) | 0/16 (0%) | 8/16 (50%) |
| Sleep Hygiene (SH) | 0/17 (0%) | 0/17 (0%) | 6/17 (35.3%) |
| Event | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) |
|---|---|---|
| Back pain/spasmMusculoskeletal and connective tissue disorders | 3/16 | 2/17 |
| Leg painMusculoskeletal and connective tissue disorders | 2/16 | 1/17 |
| Arm and chest painCardiac disorders | 2/16 | 0/17 |
| Mild rash (actigraph)Skin and subcutaneous tissue disorders | 0/16 | 2/17 |
| Root canal infectionInfections and infestations | 1/16 | 0/17 |
| Cellulitis (foot)Infections and infestations | 0/16 | 1/17 |
| Ear infectionEar and labyrinth disorders | 0/16 | 1/17 |
| Scratched corneaEye disorders | 0/16 | 1/17 |
| InfectionInfections and infestations | 0/16 | 1/17 |
The baseline population includes those who consented to participate in the study and were randomized to the SH arm or SH+Y arm.
| Age, Categorical(Participants) | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 15 | 29 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) | Total |
|---|---|---|---|
| Mean | 44.44 ± 14.74 | 47.29 ± 10.83 | 45.91 ± 13.09 |
| Sex: Female, Male(Participants) | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) | Total |
|---|---|---|---|
| Female | 15 | 15 | 30 |
| Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 7 | 13 |
| Not Hispanic or Latino | 10 | 9 | 19 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 8 | 14 |
| White | 3 | 2 | 5 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Sleep Duration(minutes/night) | Sleep Hygiene & Yoga (SH+Y) | Sleep Hygiene (SH) | Total |
|---|---|---|---|
| Mean | 400.69 ± 75.45 | 418.06 ± 66.07 | 409.37 ± 70.24 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2018, 5 months.
Results were first posted in Aug 2019, 1 year 1 month after primary completion.
Of 75 non-industry interventional studies with no phase under Sleep Hygiene, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 5 months is below that.
Counting every sponsor, half of 79 studies reached it within 8 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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