The Impact of Insomnia on Pain in HIV
关键词
抽象
描述
Experimental session 1 Resting Blood Pressure and Body Mass Index will be assessed. Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test. Study staff will administer the Structured Interview for Sleep Disorders and administer the Rapid Estimation of Adult Literacy Measure-Short Form (REALM-SF) to determine health literacy. The night of Experimental Session 1 participant will be using a Resmed ApneaLink Air device (Resmed, San Diego, CA), to identify apnea and hypopnea and calculate an apnea hypopnea index.
Between Experimental Session 1 and Experimental Session 2 Sleep assessment: Sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. Participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1. Participant will be provided with a watch-like device to wear on wrist for 7 consecutive days and nights. This watch measures physical activity and sleep.
Experimental Session 2 Resting Blood Pressure and temperature will be assessed. A sample of urine will be taken to test for illicit substances that might affect the study's results. Experimental session 2 will take place in the Center for Clinical and Translational Science (CCTS) Clinical Research Unit (CRU). A clinical Research Unit (CRU) nurse will place an intravenous (IV) cannula (small plastic tube) in the arm using a needle to draw blood at the beginning of the session and then an additional four times across the study for a total of five blood draws. Participants will complete multiple questionnaires to measure health, and experience with insomnia, pain, mood and emotions, experiences with stigma and discrimination, and how participant thinks and feels about things. All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 3-4 hours. Blood will be processed and stored and then used to measure inflammation.
Weekly Follow-up Sessions Participants will then complete a battery of ecologically valid movement tasks that include: 1) Performance Battery (SPPB) which includes sitting in a chair, transitioning to a standing position, balancing tests and gait speed, and the Timed Up and Go test (TUG). A clinical Research Unit (CRU) nurse will draw a quick sample of approximately 20 milliliters from the participants arm using a butterfly needle so that CRU nurse can collect blood during the beginning of each visit.
日期
最后验证: | 02/29/2020 |
首次提交: | 02/19/2020 |
提交的预估入学人数: | 03/02/2020 |
首次发布: | 03/05/2020 |
上次提交的更新: | 03/04/2020 |
最近更新发布: | 03/08/2020 |
实际学习开始日期: | 12/31/2019 |
预计主要完成日期: | 07/30/2023 |
预计完成日期: | 07/30/2023 |
状况或疾病
干预/治疗
Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised
Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA).
Other: Quantitative Sensory testing (QST)
Diagnostic Test: OraQuick Advance Rapid HIV 1/2 Swab test
Diagnostic Test: Cluster of Differentiation 4 (CD4) and Viral load
相
手臂组
臂 | 干预/治疗 |
---|---|
HIV and Insomnia Participants will test positive for HIV and Insomnia. | |
HIV Without Insomnia Participants will test positive for HIV and test negative for Insomnia. | |
Non HIV with Insomnia Participants will test negative for HIV and test positive for Insomnia. | |
Non HIV Without Insomnia Participants will test negative for HIV and test negative for Insomnia. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: HIV with Insomnia - Confirmed HIV diagnosis - currently a patient in the University of Alabama (UAB) 1917 HIV Clinic. - must be currently receiving stable antiretroviral therapy (ART). - Meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty. HIV Without Insomnia - Confirmed HIV diagnosis - currently a patient in the University of Alabama (UAB) 1917 HIV Clinic. - must be currently receiving stable antiretroviral therapy (ART). - Does not meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty. Non HIV with Insomnia - Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic. - Meets DSM-5 diagnostic criteria for insomnia including sleep difficulty. Non HIV Without Insomnia - Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic. - Does not meets DSM-5 diagnostic criteria for insomnia including sleep difficulty. Exclusion Criteria: - concurrent medical conditions that could confound - interpretation of sleep - pain - inflammatory issues or coexisting diseases - Systemic rheumatic disease/condition - uncontrolled hypertension (i.e., BP > 150/95) - circulatory disorders (e.g., Reynaud's disease) - history of heart disease or cardiac events - history of cancer - asthma AND use of an inhaler - history of seizures - history of stroke or other neurological disorder - pregnancy - core body temperature > 100 degrees Fahrenheit as this could indicate acute infection with fever; (k) - unwilling to provide blood for this study - non-English speaking - recent injury or surgical procedure within past 6 months. |
结果
主要结果指标
1. Pro-Inflammatory markers [Baseline up to 8 weeks]
2. Anti-Inflammatory markers [Baseline up to 8 weeks]
3. Oxidative Stress markers [Baseline up to 8 weeks]
4. Pain threshold [Baseline up to 1 week]
5. Pain tolerance [Baseline up to 1 week]
6. Punctate Stimuli [Baseline up to 1 week]
7. Temporal summation of pain [Baseline up to 1 week]
8. Conditioned pain modulation [Baseline up to 1 week]
9. Actigraph Sleep Measurement [Baseline up to 8 weeks]
10. Weekly Sleep Diaries [Baseline up to 8 weeks]
11. Weekly Caffeine Diaries [Baseline up to 8 weeks]
次要成果指标
1. Short Physical Performance Battery [Week 2 up to 8 weeks]
其他成果措施
1. Timed Up and Go (TUG) Task [Week 2 up to 8 weeks]
2. Munich Chrono Type Questionnaires (MCTQ) [Baseline]
3. Insomnia Severity Index (ISI) [Baseline up to 8 weeks]
4. Demographics (DEMO) [Baseline]
5. Center for Epidemiological Studies - Depression (CESD) [Baseline up to 8 weeks]
6. RU Sated [Baseline up to 8 weeks]
7. Physical Health Questionnaire (PHQ-15) [Baseline]
8. Difficulties in Emotion Regulation Scale (DERS) [Baseline]
9. Dysfunctional Beliefs and Attitudes about Sleep (DBAAS) [Baseline]
10. Pain Interference and Intensity (PI-I) [week 1 up to 7 weeks]
11. Sorge 24 Hour Food Record [Baseline up to 1 week]
12. Sorge Dietary Habits [Baseline up to 1 week]
13. Drug Abuse Screening Test (DAST10) [Baseline up to 1 week]
14. State Trait Anxiety Inventory [Baseline up to 1 week]
15. Penn State Cigarette Dependence Index - Cigarettes [Baseline up to 1 week]
16. Penn State Cigarette Dependence Index - Ecigarettes [Baseline up to 1 week]
17. Alcohol Use Disorders Identification Test - C (AUDIT) [Baseline up to 1 week]
18. Alcohol Smoking and Substance Involvement Screening Test (ASSIST) [Baseline up to 1 week]
19. Anger PROMIS [Baseline up to 1 week]
20. Perceived Stress Scale (PSS) [Baseline up to 1 week]
21. Pain Catastrophizing Scale (PCS) [Baseline up to 1 week]
22. HIV Stigma Mechanisms [Baseline up to 1 week]
23. Heightened Vigilance Scale (HVS) [Baseline up to 1 week]
24. Experience of Discrimination (EOD) [Baseline up to 1 week]
25. Adverse Childhood Experiences (ACE) [Baseline up to 1 week]
26. Lee Fatigue Scale (LFS) [Baseline up to 1 week]