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Completed

NCT Number: NCT03535636

Sleep Impairments in Refugees Diagnosed With PTSD

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.

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Key information

Conditions

PTSD Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Competence Center for Transcultural Psychiatry

Ballerup Municipality, 2750, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Other

Sleep architecture will be assessed by polysomnography

Primary outcomes

  1. 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

  1. Global Assessment of Functioning (GAF S + F)

    Time frame: 10 minutes

    A numeric scale used to subjectively rate the social, occupational, and psychological functioning of an individual

  2. Harvard Trauma Questionnaire (HTQ)

    Time frame: 10 minutes

    Assessing PTSD symptoms

  3. Hopkins Symptom Check List-25 (HSCL-25)

    Time frame: 10 minutes

    Assessing anxiety and depression symptoms

  4. World Health Organization Well-Being Index (WHO-5)

    Time frame: 10 minutes

    Assessing subjective psychological well-being

  5. Sheehan Disability Scale (SDS)

    Time frame: 10 minutes

    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.

  6. Schedule for Clinical Assessment in Neuropsychiatry (SCAN)

    Time frame: 1 hours

    Diagnosing and measuring mental illness that may occur in adult life.

  7. Clinician Administered PTSD Scale (CAPS-5)

    Time frame: 1 hour

    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).

  8. Hamilton depression scale (HAM-D17)

    Time frame: 15 minutes

    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.

  9. Hamilton anxiety scale (HAM-A14)

    Time frame: 15 minutes

    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.

  10. The Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 10 minutes

    Assessing sleep quality and sleep disorders

  11. Disturbing dreams and Nightmare Severity Index (DDNSI)

    Time frame: 10 minutes

    Assessing nightmares

  12. REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)

    Time frame: 10 minutes

    Assessing REM Sleep Behavior Disorders

  13. Life Events Checklist for DSM-5 (LEC-5) - extended version

    Time frame: 10 minutes

    Screening of potential traumatic events

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Danish Center for Sleep Medicine

Registry information

Official study title

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

Acronym: PSG-PTSD

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 24, 2018
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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