NCT03535636

Brief Summary

The aim of this study is to examine sleep architecture in refugees with PTSD. Polysomnography (PSG) will be carried out to study the occurrence of sleep disorders in patients and healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 20, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

4.8 years

First QC Date

April 24, 2018

Last Update Submit

February 22, 2023

Conditions

PTSDSleep Disorder

Keywords

PolysomnographyRefugees

Outcome Measures

Primary Outcomes (1)

  • Assessing the incidence of sleep disorders in refugees with PTSD

    Sleep architecture will be assessed by polysomnography. The recording of brain activity during sleep will reveal the incidence of sleep disorders such as sleep apnea, REM sleep without atonia and REM sleep behaviour disorder

    12 hours

Secondary Outcomes (13)

  • Global Assessment of Functioning (GAF S + F)

    10 minutes

  • Harvard Trauma Questionnaire (HTQ)

    10 minutes

  • Hopkins Symptom Check List-25 (HSCL-25)

    10 minutes

  • World Health Organization Well-Being Index (WHO-5)

    10 minutes

  • Sheehan Disability Scale (SDS)

    10 minutes

  • +8 more secondary outcomes

Study Arms (2)

Refugees with PTSD

Adults over the age of 18. Refugees or family members of refugees that has been reunited. PTSD (ICD-10 criteria) and written consent. No drug or alcohol abuse and no medication that can affect sleep rhythms, such as antipsychotic drugs, benzodiazepine, opioids, antihistamine or CNS stimulating drugs. A BMI under 35 and no pregnancy.

Other: Polysomnography

Healthy controls

Matched on age, sex and BMI and signed written consent. No mental illness, drug or alcohol abuse and medication. No pregnancy.

Other: Polysomnography

Interventions

PolysomnographyOTHER

Sleep architecture will be assessed by polysomnography

Healthy controlsRefugees with PTSD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population includes patients referred to the specialised outpatient clinic 'Competence Centre for Transcultural Psychiatry' (CTP) in Denmark. The clinic treats adult refugees, migrants or people with family reunification who has a traumatic background eg. imprisonment with torture, organised violence, long term political pursuit or war experiences. The patients at the clinic has PTSD, depression and/or anxiety. Healthy control subjects are matched on age, sex and BMI.

You may qualify if:

  • Adults (18 years old or above)
  • Refugee or family reunification refugees
  • PTSD according to the ICD-10 criteria's
  • Signed informed concent

You may not qualify if:

  • Severe psychotic disorder (defined as patients with ICD-10 diagnoses F2x and F30.1-F30.9)
  • Harmful use of alcohol (ICD-10 diagnosis F1x.1)
  • Serious or progressive somatic illnesses that the lead investigator finds interfering for the study
  • Medical treatment with antipsychotics, benzodiazepine, opioids, CNS stimulants or regular use of anti histamine
  • BMI \>35
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Competence Center for Transcultural Psychiatry

Ballerup Municipality, 2750, Denmark

Location

Related Publications (1)

  • Ansbjerg MB, Sandahl H, Baandrup L, Jennum P, Carlsson J. Sleep impairments in refugees diagnosed with post-traumatic stress disorder: a polysomnographic and self-report study. Eur J Psychotraumatol. 2023;14(1):2185943. doi: 10.1080/20008066.2023.2185943.

    PMID: 36971225DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSleep Wake Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pregraduate Researcher

Study Record Dates

First Submitted

April 24, 2018

First Posted

May 24, 2018

Study Start

April 20, 2018

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)