Sleep Impairments in Refugees Diagnosed With PTSD - A Polysomnographic and Self-report Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assessing the incidence of sleep disorders in refugees with PTSD
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (18 years old or above)
- •Refugee or family reunification refugees
- •PTSD according to the ICD-10 criteria's
- •Signed informed concent
排除标准
- •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
- •Pregnancy
结局指标
主要结局
Assessing the incidence of sleep disorders in refugees with PTSD
时间窗: 12 hours
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
次要结局
- Global Assessment of Functioning (GAF S + F)(10 minutes)
- Harvard Trauma Questionnaire (HTQ)(10 minutes)
- Hopkins Symptom Check List-25 (HSCL-25)(10 minutes)
- World Health Organization Well-Being Index (WHO-5)(10 minutes)
- Sheehan Disability Scale (SDS)(10 minutes)
- Schedule for Clinical Assessment in Neuropsychiatry (SCAN)(1 hours)
- Clinician Administered PTSD Scale (CAPS-5)(1 hour)
- Hamilton depression scale (HAM-D17)(15 minutes)
- Hamilton anxiety scale (HAM-A14)(15 minutes)
- The Pittsburgh Sleep Quality Index (PSQI)(10 minutes)
- Disturbing dreams and Nightmare Severity Index (DDNSI)(10 minutes)
- REM Sleep Behavior Disorder Screening Questionnaire (RBDSC)(10 minutes)
- Life Events Checklist for DSM-5 (LEC-5) - extended version(10 minutes)
研究者
Mia Beicher Ansbjerg
Pregraduate Researcher
Mental Health Services in the Capital Region, Denmark