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SleepNCT07566481

Stress, Coping, and Sleep Health Study

An observational study of Sleep, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Background: Poor sleep is common among refugee groups worldwide. It can lead to an increased risk of heart disease, diabetes, cancer, and premature death. It can also worsen mental health disorders. Researchers have studied the mental health issues among refugees from Bhutan in the United States. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Sleep
How many people
70 participants
Where
1 siteUnited States
Study dates
29 Oct 2026to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will enroll between 48-60 adults (18+ years) living in Ohio, US for Focus Group Discussions and 10 adults (18+ years) who work with or support Bhutanese Refugees living in Ohio.

Who may be able to join

  • In order to be eligible to participate in a FGD for this study, an individual must meet all of the following criteria:
  • Adult (aged 18 years or older) living in Ohio, US
  • Self-identify as Bhutanese-Nepali or Bhutanese American
  • Identify as a refugee
  • Speak and understand English and/or Nepali.
  • Ability to understand and the willingness to provide informed consent and participate in the FGD
Show all 10Show fewer
  • In order to be eligible to participate in a KII for this study, an individual must meet all of the following criteria:
  • Adult (aged 18 years or older)
  • Ability to speak and understand English; Familiarity with the lives and experiences of Bhutanese refugees living in Ohio, US
  • Ability to understand and the willingness to provide informed consent and participate in the virtual KII.

Who cannot join

  • Individuals who are unable to communicate in either English or Nepali will be excluded from FGD. Since Nepali is the primary language spoken by most Bhutanese refugees before relocation, and English is the dominant language in the United States, participants are expected to have sufficient proficiency in at least one of these languages.
  • Individuals who are unable to communicate in English will be excluded from KII. Given their leadership roles and interactions with the healthcare system, educational institutions, local government service providers, and nonprofit organizations in Ohio-where English is the primary language-participants are expected to have sufficient English proficiency. We will not exclude any participants that meet the inclusion criteria from participating in the study overall or in any of the study procedures.
  • Children (individuals under 18) are excluded from this study because the knowledge sought is not relevant to this population. This study investigates the relationship between sleep quality and experiences of discrimination among Bhutanese-Nepali refugees in Ohio, as well as the coping mechanisms adults use to manage discrimination-related stress, particularly as it pertains to sleep.
  • The constructs under investigation, including perceived discrimination, its psychosocial impact, and adaptive coping strategies, are anchored in the adult experience of resettlement and the stressors associated with adult social and occupational life. Children's experiences of discrimination, sleep patterns, and coping mechanisms differ substantially from those of adults in both nature and context, and findings from an adult sample would not be generalizable to a pediatric population. For these reasons, the inclusion of children would not yield scientifically meaningful data relevant to the study aims.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chandra L Jackson, Ph.D. contact

(984) 297-3701

chandra.jackson@nih.gov

United States1 site
  • Bhutanese Community of Central Ohio

    Columbus, Ohio, 43229

    Sudarshan Pyakurel, 614-396-8965, spyakurel@bccoh.org

Other trials in United States

About this study

Background:

Poor sleep is common among refugee groups worldwide. It can lead to an increased risk of heart disease, diabetes, cancer, and premature death. It can also worsen mental health disorders. Researchers have studied the mental health issues among refugees from Bhutan in the United States. Now they want to understand more about how difficulty sleeping may relate to their other health outcomes.

Read more

Objective:

To learn how the social and environmental conditions Bhutanese refugees affect their sleep health and health outcomes.

Eligibility:

Refugees aged 18 years and older of Bhutanese-Nepali or Bhutanese American descent. The participants must live in central Ohio. Also needed are people aged 18 years and older who interact with Bhutanese refugees in this region.

Design:

Participants will participate in a focus group discussion. The group will have 8 to 10 participants. It will last 60 to 90 minutes.

They will talk about their experiences as a refugee and their sleep health. Topics may include adjusting to a new culture; access to housing and health care; and experiences with differential treatment by members inside and outside of their group. The study team will audio record the discussion. They will not share the recording with anyone.

Participants will complete a short questionnaire. They will answer questions about their age, sex, language preferences, and how long they have lived in the United States.

Participants who are not refugees will take part in a virtual interview led by a member of the study team. Participants will share their experiences with adapting to a new culture, differential treatment, and other factors have affected refugees sleep. The interview will take about 1 hour.

Read the detailed description

Study Description:

This qualitative study seeks to examine the role of discrimination, acculturative stressors, and coping mechanisms in shaping the sleep health of Bhutanese refugees living in Central Ohio. Using focus group discussions (n=approximately 6) with Bhutanese refugees and key informant interviews (n=approximately 10) with community leaders, the study will examine associations between refugee-related stressors-such as trauma, discrimination, and acculturation challenges-and sleep health. It will also explore coping strategies employed in response to sleep difficulties, experiences of discrimination, and other stressors, and identify recommendations for enhanced community resources and support.

Objectives:

The primary objectives of this study include:

  1. Investigate associations between stressors related to being a refugee (e.g., trauma, financial strain, discrimination, acculturation, political) and various sleep health dimensions.
  2. Identify coping strategies used in response to difficulties with sleep, discriminatory experiences, and other stressors.
  3. Determine recommendations regarding the types of support and resources needed by the Bhutanese refugee community to manage stressors and support sleep health.

Endpoints:

We will confirm that our study's primary objectives have been met once data saturation is achieved-that is, when no new themes, insights, or significant patterns emerge, indicating a comprehensive understanding of our three key research objectives. Additionally, we will evaluate whether the collected data contain sufficient depth, diversity of perspectives, and contextual detail to fully address our central research questions. This assessment will involve triangulation, using various data sources (e.g., Key Informant Interviews and Focus Group Discussions) to identify areas of thematic convergence.

Conditions
Sleep
Keywords
Refugee, Sleep, Discrimination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07566481
Study groupRoleWhat they receive
US BhutaneseThose self-identifying as Bhutanese living in central Ohio.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigate associations between stressors related to being a refugee (e.g., trauma, financial strain, discrimination, acculturation, political) and various sleep health dimensions.

    We will confirm that our study's primary objectives have been met once data saturation is achieved-that is, when no new themes, insights, or significant patterns emerge, indicating a comprehensive understanding of our three key research objectives. Additionally, we will evaluate whether the collected data is sufficiently rich and detailed to fully address our central research questions. This assessment will involve triangulation using various data sources (e.g., Key Informant Interviews and Focus Group Discussions) to identify areas of thematic convergence

    Measured: Will use qualitative best practices to determine when study objectives have been sufficiently achieved.

  2. Identify coping strategies used in response to difficulties with sleep, discriminatory experiences, and other stressors.

    We will confirm that our study's primary objectives have been met once data saturation is achieved-that is, when no new themes, insights, or significant patterns emerge, indicating a comprehensive understanding of our three key research objectives. Additionally, we will evaluate whether the collected data is sufficiently rich and detailed to fully address our central research questions. This assessment will involve triangulation using various data sources (e.g., Key Informant Interviews and Focus Group Discussions) to identify areas of thematic convergence

    Measured: Will use qualitative best practices to determine when study objectives have been sufficiently achieved.

  3. Determine recommendations regarding the types of support and resources needed by the Bhutanese refugee community to manage stressors and support sleep health.

    We will confirm that our study's primary objectives have been met once data saturation is achieved-that is, when no new themes, insights, or significant patterns emerge, indicating a comprehensive understanding of our three key research objectives. Additionally, we will evaluate whether the collected data is sufficiently rich and detailed to fully address our central research questions. This assessment will involve triangulation using various data sources (e.g., Key Informant Interviews and Focus Group Discussions) to identify areas of thematic convergence

    Measured: Will use qualitative best practices to determine when study objectives have been sufficiently achieved.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2026
  2. Study start29 Oct 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07566481
Sponsor's protocol ID
10002390
Other IDs
002390-E
Status last verified
3 Sep 2026
First submitted
2 May 2026
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.

    PubMed 34785096
  • Patton MQ. Enhancing the quality and credibility of qualitative analysis. Health Serv Res. 1999 Dec;34(5 Pt 2):1189-208.

    PubMed 10591279
  • Misra SM, Nepal VP, Banerjee D, Giardino AP. Chronic Health Conditions, Physical Activity and Dietary Behaviors of Bhutanese Refugees: A Houston-Based Needs Assessment. J Immigr Minor Health. 2016 Dec;18(6):1423-1431. doi: 10.1007/s10903-015-0282-1.

    PubMed 26458956
  • Liu RT, Steele SJ, Hamilton JL, Do QBP, Furbish K, Burke TA, Martinez AP, Gerlus N. Sleep and suicide: A systematic review and meta-analysis of longitudinal studies. Clin Psychol Rev. 2020 Nov;81:101895. doi: 10.1016/j.cpr.2020.101895. Epub 2020 Aug 8.

    PubMed 32801085
  • Scott AJ, Webb TL, Martyn-St James M, Rowse G, Weich S. Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Dec;60:101556. doi: 10.1016/j.smrv.2021.101556. Epub 2021 Sep 23.

    PubMed 34607184
  • Jou YC, Pace-Schott EF. Call to action: Addressing sleep disturbances, a hallmark symptom of PTSD, for refugees, asylum seekers, and internally displaced persons. Sleep Health. 2022 Dec;8(6):593-600. doi: 10.1016/j.sleh.2022.09.003. Epub 2022 Oct 27.

    PubMed 36511279
  • Lies J, Mellor A, Jobson L, Drummond SPA. Prevalence of sleep disturbance and its relationships with mental health and psychosocial issues in refugees and asylum seekers attending psychological services in Australia. Sleep Health. 2019 Aug;5(4):335-343. doi: 10.1016/j.sleh.2019.06.002. Epub 2019 Jul 16.

    PubMed 31320291
  • Lies J, Drummond SPA, Jobson L. Longitudinal investigation of the relationships between trauma exposure, post-migration stress, sleep disturbance, and mental health in Syrian refugees. Eur J Psychotraumatol. 2020 Nov 19;11(1):1825166. doi: 10.1080/20008198.2020.1825166.

    PubMed 33425241
  • Subedi P, Li C, Gurung A, Bizune D, Dogbey MC, Johnson CC, Yun K. Mental health first aid training for the Bhutanese refugee community in the United States. Int J Ment Health Syst. 2015 May 9;9:20. doi: 10.1186/s13033-015-0012-z. eCollection 2015.

    PubMed 25987894
  • Aernout E, Benradia I, Hazo JB, Sy A, Askevis-Leherpeux F, Sebbane D, Roelandt JL. International study of the prevalence and factors associated with insomnia in the general population. Sleep Med. 2021 Jun;82:186-192. doi: 10.1016/j.sleep.2021.03.028. Epub 2021 Apr 2.

    PubMed 33957414
  • Baskaran A, Marogi E, Bitar R, Attarian H, Saadi A. Improving Sleep Health Among Refugees: A Systematic Review. Neurol Clin Pract. 2023 Apr;13(2):e200139. doi: 10.1212/CPJ.0000000000200139. Epub 2023 Mar 14.

    PubMed 36936393
  • Hagaman AK, Sivilli TI, Ao T, Blanton C, Ellis H, Lopes Cardozo B, Shetty S. An Investigation into Suicides Among Bhutanese Refugees Resettled in the United States Between 2008 and 2011. J Immigr Minor Health. 2016 Aug;18(4):819-827. doi: 10.1007/s10903-015-0326-6.

    PubMed 26758579
  • Ao T, Shetty S, Sivilli T, Blanton C, Ellis H, Geltman PL, Cochran J, Taylor E, Lankau EW, Lopes Cardozo B. Suicidal Ideation and Mental Health of Bhutanese Refugees in the United States. J Immigr Minor Health. 2016 Aug;18(4):828-835. doi: 10.1007/s10903-015-0325-7.

    PubMed 26711245
  • Polcher K, Calloway S. Addressing the Need for Mental Health Screening of Newly Resettled Refugees: A Pilot Project. J Prim Care Community Health. 2016 Jul;7(3):199-203. doi: 10.1177/2150131916636630. Epub 2016 Mar 4.

    PubMed 26944513
  • Torres L, Driscoll MW, Voell M. Discrimination, acculturation, acculturative stress, and Latino psychological distress: a moderated mediational model. Cultur Divers Ethnic Minor Psychol. 2012 Jan;18(1):17-25. doi: 10.1037/a0026710.

    PubMed 22250895

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chandra L Jackson, Ph.D. ((984) 297-3701, chandra.jackson@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigate associations between stressors related to being a refugee (e.g., trauma, financial strain, discrimination, acculturation, political) and various sleep health dimensions. (time frame: Will use qualitative best practices to determine when study objectives have been sufficiently achieved.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07566481, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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