Sleep Impairments in Refugees Diagnosed With PTSD

NCT ID: NCT03535636

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-20

Study Completion Date

2023-02-07

Brief Summary

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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

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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.

Conditions

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PTSD Sleep Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Polysomnography

Intervention Type OTHER

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.

Polysomnography

Intervention Type OTHER

Sleep architecture will be assessed by polysomnography

Interventions

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Polysomnography

Sleep architecture will be assessed by polysomnography

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Center for Sleep Medicine

OTHER

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Mia Beicher Ansbjerg

Pregraduate Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Competence Center for Transcultural Psychiatry

Ballerup Municipality, , Denmark

Site Status

Countries

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Denmark

References

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Ansbjerg MB, Sandahl H, Baandrup L, Jennum P, Carlsson J. Sleep impairments in refugees diagnosed with post-traumatic stress disorder: a polysomnographic and self-report study. Eur J Psychotraumatol. 2023;14(1):2185943. doi: 10.1080/20008066.2023.2185943.

Reference Type DERIVED
PMID: 36971225 (View on PubMed)

Other Identifiers

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PSG-PTSD

Identifier Type: -

Identifier Source: org_study_id

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