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

M

Mental Health Services in the Capital Region, Denmark

Status

Completed

Conditions

PTSD
Sleep Disorder

Treatments

Other: Polysomnography

Study type

Observational

Funder types

Other

Identifiers

NCT03535636
PSG-PTSD

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Refugees with PTSD
Description:
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.
Treatment:
Other: Polysomnography
Healthy controls
Description:
Matched on age, sex and BMI and signed written consent. No mental illness, drug or alcohol abuse and medication. No pregnancy.
Treatment:
Other: Polysomnography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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