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临床试验/NCT03866161
NCT03866161招募中不适用

The Effect of Positive Pressure Therapy (CPAP) in Patients With Obstructive Sleep Apnea on Cognitive Functions, Anxiety, and Affective Symptoms

University Hospital Olomouc1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Change in d2 Test after 1 year of PAP treatment

研究概览

简要总结

Long term, prospective study of continuous positive airway pressure treatment influence on cognitive functions in patients with obstructive sleep apnea syndrome.

详细描述

Brief summary:

The aim of work is to assess the extent of anxiety and affective disorders symptoms and cognitive performance in newly diagnosed patients with obstructive sleep apnea. In the second phase, follow the changes in these areas after 2 months and after 1 year of continuous treatment. The investigators can then compare the change of symptoms and cognitive performance in terms of compliance with treatment.

Course:

Recent papers discus the interconnection of anxiety and affective disorders and the deterioration of cognitive functions in patients with untreated obstructive sleep apnea. Contemporary literature also describes the effect of PAP on affective and anxiety disorders, but the results of published works are controversial and often contradictory. The effect of OSA treatment on cognitive function is explored more and studies show improvement of cognitive function while adhering to regular overpressure breathing at night. In this study patients diagnosed with OSA (Porti 7- F + G, Germany or Alice 5- Respironics, USA) indicated for PAP (AHI> 15) therapy admitted for PAP pressure adjustment will be given by investigator The Epworth Sleepiness Scale, Beck's anxiety inventory and Beck's depression inventory. Then each participant will undergo clinical examination by the investigator using Mini-International Neuropsychiatric Interview to assess whether the participant meets the ICD-10 criteria for major depressive disorder. In the next step each participant will complete three given cognitive tests (Trail making test, D2 test, Controlled Oral Word Association Test). Results of the cognitive test will be adjusted for age and compared with the population norms for each test to assess the presence of cognitive impairment at the beginning of treatment. In the next phase participants will use PAP device in the home environment for two months. At outpatient control after 2 months, participants will complete Beck's anxiety inventory and Beck's depression inventory and Epworth sleepiness scale. In the last phase participants will use PAP device for another 10 months in the home environment so the total period of treatment will be 1 year. At the outpatient control after 1 year of treatment participants will complete Beck's anxiety inventory and Beck's depression inventory and Epworth sleepiness scale, each participant will then again complete three given cognitive tests (Trail making test, D2 test, Controlled Oral Word Association Test). Information on average use over a 1-year period and compliance with treatment will be provided from the PAP device. Participants will be then divided into two groups, compliant (over 4 hours of PAP treatment per night on average) and non-compliant (less then 4 hours of PAP treatment per night on average) and the data from the questionnaires and cognitive tests will be compared.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy, i.e. Apnea-Hypopnea index AHI> 15

排除标准

  • Psychiatric treatment
  • Treatment with psychoactive drugs

结局指标

主要结局

Change in d2 Test after 1 year of PAP treatment

时间窗: 1 year of PAP treatment

Statistically significant change in results of d2 Test in comparison with the pre-treatment results. d2 Test of attention is standardized test of selective and sustained attention and visual scanning speed. Results are measured as a number of mistakes made in 14 lines of symbols, in which patients mark three given symbols. Patient has 20 seconds for each line. Higher number of mistakes represents worse outcome as it points to cognitive impairment. Standardized population norms will be used to assess the results.

Change of affective symptoms after 1 year of PAP treatment

时间窗: 1 year of PAP treatment

Statistically significant change in the scores of Beck Depression Inventory. The total score is calculated as a sum of 21 multiple choice items. Score 0-9: indicates minimal depression, 10-18: indicates mild depression, 19-29: indicates moderate depression, 30-63: indicates severe depression.

Change of anxiety symptoms after 1 year of PAP treatment

时间窗: 1 year of PAP treatment

Statistically significant change in the scores of Beck Anxiety Inventory over the 1-year period of PAP treatment. The total score is calculated as a sum of the 21 items. Score of 0-21 = low anxiety. Score of 22-35 = moderate anxiety. Score of 36 and above = potentially concerning levels of anxiety.

Change in Trail making test after 1 year of PAP treatment

时间窗: 1 year of PAP treatment

Statistically significant change in results of Trail making test in comparison with the pre-treatment results. Trail making test is measured in seconds as a time needed to complete trail from first to last point. Higher performing times represent worse outcomes as it points to cognitive impairment. Standardized population norms adjusted for age will be used to assess the results.

Change in Controlled Oral Word Association Test after 1 year of PAP treatment

时间窗: 1 year of PAP treatment

Statistically significant change in results of Controlled Oral Word Association Test in comparison with the pre-treatment results. Controlled Oral Word Association Test measures spontaneous production of words beginning with some designated letter. For each of three given letters patient has 1 minute to produce as much words as possible. Total count of words will be compared, the higher count of words represents better outcome. Standardized population norms adjusted for age and education will be used to assess the results.

次要结局

  • Performance in Trail making test in untreated OSA patients compared to population norms.(1 year of PAP treatment)
  • The difference between compliant and non-compliant patients in affective symptoms after 1 year follow up.(1 year of PAP treatment)
  • The difference between compliant and non-compliant patients in Trail making test after 1 year follow up.(1 year of PAP treatment)
  • Performance in Controlled Oral Word Association Test in untreated OSA patients compared to population norms.(1 year of PAP treatment)
  • The difference between compliant and non-compliant patients in anxiety symptoms after 1 year follow up.(1 year of PAP treatment)
  • Performance in d2 Test in untreated OSA patients compared to population norms.(1 year of PAP treatment)
  • The difference between compliant and non-compliant patients in Controlled Oral Word Association Test after 1 year follow up.(1 year of PAP treatment)
  • The difference between compliant and non-compliant patients in d2 Test after 1 year follow up.(1 year of PAP treatment)

研究者

发起方
University Hospital Olomouc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Milan Sova

Head of Sleep laboratory, Department of Respiratory Medicine

University Hospital Olomouc

研究点 (1)

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