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PTSDPSG-PTSDNCT03535636

Sleep Impairments in Refugees Diagnosed With PTSD

An observational study of PTSD and Sleep Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
PTSD, Sleep Disorder
What is being tested?
Polysomnography
How many people
40 participants
Where
1 siteDenmark
Study dates
20 Apr 2018to 7 Feb 2023
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Adults (18 years old or above)
  • Refugee or family reunification refugees
  • PTSD according to the ICD-10 criteria's
  • Signed informed concent

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • Competence Center for Transcultural Psychiatry

    Ballerup Municipality, 2750

Other trials in Denmark

About this study

Official title: 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.

Read the 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.

Conditions
PTSD, Sleep Disorder
Being tested
Polysomnography
Keywords
Polysomnography, Refugees
Medical subject headings
Stress Disorders, Post-Traumatic, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PolysomnographyOther

    Sleep architecture will be assessed by polysomnography

Study groups in NCT03535636
Study groupRoleWhat they receive
Refugees with PTSDAdults 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.
Receives: Other: Polysomnography
Healthy controlsMatched on age, sex and BMI and signed written consent. No mental illness, drug or alcohol abuse and medication. No pregnancy.
Receives: Other: Polysomnography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 hours

Secondary outcomes (13)

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

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

    Measured: 10 minutes

  2. Harvard Trauma Questionnaire (HTQ)

    Assessing PTSD symptoms

    Measured: 10 minutes

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

    Assessing anxiety and depression symptoms

    Measured: 10 minutes

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

    Assessing subjective psychological well-being

    Measured: 10 minutes

  5. 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.

    Measured: 10 minutes

  6. Schedule for Clinical Assessment in Neuropsychiatry (SCAN)

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

    Measured: 1 hours

  7. 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).

    Measured: 1 hour

  8. 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.

    Measured: 15 minutes

  9. 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.

    Measured: 15 minutes

  10. The Pittsburgh Sleep Quality Index (PSQI)

    Assessing sleep quality and sleep disorders

    Measured: 10 minutes

  11. Disturbing dreams and Nightmare Severity Index (DDNSI)

    Assessing nightmares

    Measured: 10 minutes

  12. REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)

    Assessing REM Sleep Behavior Disorders

    Measured: 10 minutes

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

    Screening of potential traumatic events

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2018
  2. Study start20 Apr 2018
  3. Primary completion7 Feb 2023
  4. Study completion7 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03535636
Sponsor's protocol ID
PSG-PTSD
Acronym
PSG-PTSD
Status last verified
Feb 2023
First submitted
24 Apr 2018
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36971225

Questions about this trial

What is this clinical trial studying?

An observational study of PTSD and Sleep Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessing the incidence of sleep disorders in refugees with PTSD (time frame: 12 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03535636, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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