Sleep Impairments in Refugees Diagnosed With PTSD

PTSD Clinical Trial

— PSG-PTSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535636
• Other study ID #: PSG-PTSD
• Status: Completed
• Start date: April 20, 2018
• Est. completion date: February 7, 2023

Study information

• Verified date: February 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Other:
• Polysomnography
Sleep architecture will be assessed by polysomnography

Locations

Country	Name	City	State
Denmark	Competence Center for Transcultural Psychiatry	Ballerup

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Danish Center for Sleep Medicine

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 hours
Secondary	Global Assessment of Functioning (GAF S + F)	A numeric scale used to subjectively rate the social, occupational, and psychological functioning of an individual	10 minutes
Secondary	Harvard Trauma Questionnaire (HTQ)	Assessing PTSD symptoms	10 minutes
Secondary	Hopkins Symptom Check List-25 (HSCL-25)	Assessing anxiety and depression symptoms	10 minutes
Secondary	World Health Organization Well-Being Index (WHO-5)	Assessing subjective psychological well-being	10 minutes
Secondary	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.	10 minutes
Secondary	Schedule for Clinical Assessment in Neuropsychiatry (SCAN)	Diagnosing and measuring mental illness that may occur in adult life.	1 hours
Secondary	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).	1 hour
Secondary	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.	15 minutes
Secondary	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.	15 minutes
Secondary	The Pittsburgh Sleep Quality Index (PSQI)	Assessing sleep quality and sleep disorders	10 minutes
Secondary	Disturbing dreams and Nightmare Severity Index (DDNSI)	Assessing nightmares	10 minutes
Secondary	REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)	Assessing REM Sleep Behavior Disorders	10 minutes
Secondary	Life Events Checklist for DSM-5 (LEC-5) - extended version	Screening of potential traumatic events	10 minutes