Clinical trial NCT03535636: Sleep Impairments in Refugees Diagnosed With PTSD
Official title: Sleep Impairments in Refugees Diagnosed With PTSD - A Polysomnographic and Self-report Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Sleep Disorder
Keywords: Polysomnography
Refugees
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Center for Sleep Medicine
First posted: 2018-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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
* BMI \>35
* Pregnancy

Primary outcomes:
measure: Assessing the incidence of sleep disorders in refugees with PTSD
timeFrame: 12 hours
Secondary outcomes:
measure: Global Assessment of Functioning (GAF S + F)
timeFrame: 10 minutes
measure: Harvard Trauma Questionnaire (HTQ)
timeFrame: 10 minutes
measure: Hopkins Symptom Check List-25 (HSCL-25)
timeFrame: 10 minutes
measure: World Health Organization Well-Being Index (WHO-5)
timeFrame: 10 minutes
measure: Sheehan Disability Scale (SDS)
timeFrame: 10 minutes
measure: Schedule for Clinical Assessment in Neuropsychiatry (SCAN)
timeFrame: 1 hours
measure: Clinician Administered PTSD Scale (CAPS-5)
timeFrame: 1 hour
measure: Hamilton depression scale (HAM-D17)
timeFrame: 15 minutes
measure: Hamilton anxiety scale (HAM-A14)
timeFrame: 15 minutes
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 10 minutes
measure: Disturbing dreams and Nightmare Severity Index (DDNSI)
timeFrame: 10 minutes
measure: REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)
timeFrame: 10 minutes
measure: Life Events Checklist for DSM-5 (LEC-5) - extended version
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Competence Center for Transcultural Psychiatry
Study officials:
References: