NCT07566481

Brief 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. Now they want to understand more about how difficulty sleeping may relate to their other health outcomes. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 17, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 12, 2026

Status Verified

May 26, 2026

Enrollment Period

7 months

First QC Date

May 2, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

RefugeeSleepDiscrimination

Outcome Measures

Primary Outcomes (3)

  • 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

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

  • 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

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

  • 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

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

Study Arms (1)

US Bhutanese

Those self-identifying as Bhutanese living in central Ohio.

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bhutanese Community of Central Ohio

Columbus, Ohio, 43229, United States

Location

Related Publications (21)

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    PMID: 36511279BACKGROUND
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    PMID: 31320291BACKGROUND
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    PMID: 33425241BACKGROUND
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    PMID: 25987894BACKGROUND
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    PMID: 33957414BACKGROUND
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    PMID: 36936393BACKGROUND
  • 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.

    PMID: 26758579BACKGROUND
  • 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.

    PMID: 26711245BACKGROUND
  • 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.

    PMID: 26944513BACKGROUND
  • 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.

    PMID: 22250895BACKGROUND
  • Zhang M, Gurung A, Anglewicz P, Baniya K, Yun K. Discrimination and Stress Among Asian Refugee Populations During the COVID-19 Pandemic: Evidence from Bhutanese and Burmese Refugees in the USA. J Racial Ethn Health Disparities. 2022 Apr;9(2):589-597. doi: 10.1007/s40615-021-00992-y. Epub 2021 Mar 2.

    PMID: 33651371BACKGROUND
  • Salinas M, Salinas JL. "We Are from Nowhere": A Qualitative Assessment of the Impact of Collective Trauma from the Perspective of Resettled Bhutanese Refugees. Health Equity. 2021 Oct 28;5(1):762-769. doi: 10.1089/heq.2020.0116. eCollection 2021.

    PMID: 34909546BACKGROUND
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    PMID: 33993363BACKGROUND
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    PMID: 32549917BACKGROUND
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    PMID: 31264064BACKGROUND
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    PMID: 37642884BACKGROUND

Study Officials

  • Chandra L Jackson, Ph.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chandra L Jackson, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 5, 2026

Study Start (Estimated)

June 17, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 12, 2026

Record last verified: 2026-05-26

Data Sharing

IPD Sharing
Will not share

Locations