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Clinical Trials/NCT03535636
NCT03535636
Completed
Not Applicable

Sleep Impairments in Refugees Diagnosed With PTSD - A Polysomnographic and Self-report Study

Mental Health Services in the Capital Region, Denmark1 site in 1 country40 target enrollmentApril 20, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
Mental Health Services in the Capital Region, Denmark
Enrollment
40
Locations
1
Primary Endpoint
Assessing the incidence of sleep disorders in refugees with PTSD
Status
Completed
Last Updated
3 years ago

Overview

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.

Detailed Description

There is little knowledge on treatment of sleep disturbances in trauma-affected refugees and this study will be the first to record the biophysiological changes that occur during sleep in refugees with PTSD. The study is a proof-of-concept study and this will contribute with new and potentially crucial knowledge of sleep disturbances in these patients. The project is designed as a cross-sectional study with 20 refugees with PTSD referred to the specialised outpatient clinic, Competence Centre for Transcultural Psychiatry (CTP), and 20 healthy control subjects. All patients referred to CTP will be invited to an initial consultation with a doctor. During this consultation a diagnostic assessment will be performed and the clinical history will be obtained. Patients who give informed consent will be invited to participate in the project and have sleep measurements performed by PSG. Furthermore self-administered questionnaires and semi-structured interviews will be used to collect information on mental health, sleep quality, sleep length and nightmares. Each patient will be equipped with PSG equipment to do measurements at home for one night (12 hours). Healthy control subjects will fill out the same CTP standard ratings and have the same diagnostic assessment and PSG measurement. The hypothesis is that the sleep architecture in refugees with PTSD differ from healthy controls. It is suggested that refugees with PTSD have increased dream activity as well as increased incidence of sleep disorders such as rapid eye movement (REM) sleep without atonia (RSWA), REM sleep behaviour disorder (RBD), sleep apnea and periodic limb movement disorder (PLM). The study is performed in collaboration with Danish Centre for Sleep Medicine in Denmark.

Registry
clinicaltrials.gov
Start Date
April 20, 2018
End Date
February 7, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Mental Health Services in the Capital Region, Denmark
Responsible Party
Principal Investigator
Principal Investigator

Mia Beicher Ansbjerg

Pregraduate Researcher

Mental Health Services in the Capital Region, Denmark

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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
  • Pregnancy

Outcomes

Primary Outcomes

Assessing the incidence of sleep disorders in refugees with PTSD

Time Frame: 12 hours

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

Secondary Outcomes

  • 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)
  • Schedule for Clinical Assessment in Neuropsychiatry (SCAN)(1 hours)
  • Clinician Administered PTSD Scale (CAPS-5)(1 hour)
  • Hamilton depression scale (HAM-D17)(15 minutes)
  • Hamilton anxiety scale (HAM-A14)(15 minutes)
  • The Pittsburgh Sleep Quality Index (PSQI)(10 minutes)
  • Disturbing dreams and Nightmare Severity Index (DDNSI)(10 minutes)
  • REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)(10 minutes)
  • Life Events Checklist for DSM-5 (LEC-5) - extended version(10 minutes)

Study Sites (1)

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