Sleep Impairments in Refugees Diagnosed With PTSD (PSG-PTSD)

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

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Sleep Disorder
• Intervention / Treatment: Other: Polysomnography

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Denmark
  • Ballerup, Denmark, 2750
    • Competence Center for Transcultural Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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
• BMI >35
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Sleep architecture will be assessed by 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; Sleep architecture will be assessed by polysomnography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Assessment of Functioning (GAF S + F)	A numeric scale used to subjectively rate the social, occupational, and psychological functioning of an individual	10 minutes
Harvard Trauma Questionnaire (HTQ)	Assessing PTSD symptoms	10 minutes
Hopkins Symptom Check List-25 (HSCL-25)	Assessing anxiety and depression symptoms	10 minutes
World Health Organization Well-Being Index (WHO-5)	Assessing subjective psychological well-being	10 minutes
Sheehan Disability Scale (SDS)	The SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. Total score 0-30 (0 unimpaired, 30 highly impaired). Work/school (0-10), Social life (0-10), Family life/home responsibilities (0-10). Scores of ≥5 on any of the 3 scales; high scores are associated with significant functional impairment.	10 minutes
Schedule for Clinical Assessment in Neuropsychiatry (SCAN)	Diagnosing and measuring mental illness that may occur in adult life.	1 hours
Clinician Administered PTSD Scale (CAPS-5)	Assessing PTSD symptoms, including their frequency and severity. The gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview and requires the identification of a single index trauma to serve as the basis of symptom inquiry. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). A symptom cluster score may also be calculated for dissociation by summing items 19 and 20. A patient needs to have: at least one Criterion B and C symptom and at least two Criterion D and E symptoms. Criterion F is met (disturbance has lasted one month) and Criterion G is met (disturbance causes either clinically significant distress or functional impairment).	1 hour
Hamilton depression scale (HAM-D17)	Assessing a patient's severity of depression before, during, and after treatment. The HAM-D probes 17 parameters. Some items are scored on a 5-point scale, ranging from 0=not present to 4=severe; others are scored on a 3-point scale, ranging from 0=not present to 2=severe. Total score 0-52 (0 unimpaired, 52 highly impaired). The sum of all 17 items indicate the severity of depression; 0-12 = normal, 13-17 = mild depression, 18-24 = moderate depression, 24-52 severe depression.	15 minutes
Hamilton anxiety scale (HAM-A14)	Assessing the severity of a patient's anxiety. The HAM-A probes 14 items. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Total score 0-56 (0 unimpaired, 56 highly impaired). The sum of all 14 items indicate the severity of anxiety; 14-17 = mild anxiety, 18-24 = moderate anxiety, 25-30 severe anxiety.	15 minutes
The Pittsburgh Sleep Quality Index (PSQI)	Assessing sleep quality and sleep disorders	10 minutes
Disturbing dreams and Nightmare Severity Index (DDNSI)	Assessing nightmares	10 minutes
REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)	Assessing REM Sleep Behavior Disorders	10 minutes
Life Events Checklist for DSM-5 (LEC-5) - extended version	Screening of potential traumatic events	10 minutes

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Danish Center for Sleep Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Actual): February 7, 2023
• Study Completion (Actual): February 7, 2023

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Polysomnography; Refugees
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: PSG-PTSD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No