Clinical trial NCT03866161: The Effect of CPAP Treatment on Cognitive Functions, Anxiety, and Affective Symptoms
Official title: The Effect of Positive Pressure Therapy (CPAP) in Patients With Obstructive Sleep Apnea on Cognitive Functions, Anxiety, and Affective Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed obstructive sleep apnea indicated for positive airway pressure treatment

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Psychiatric treatment
* Treatment with psychoactive drugs

Primary outcomes:
measure: Change of affective symptoms after 1 year of PAP treatment
timeFrame: 1 year of PAP treatment
measure: Change of anxiety symptoms after 1 year of PAP treatment
timeFrame: 1 year of PAP treatment
measure: Change in Controlled Oral Word Association Test after 1 year of PAP treatment
timeFrame: 1 year of PAP treatment
measure: Change in d2 Test after 1 year of PAP treatment
timeFrame: 1 year of PAP treatment
measure: Change in Trail making test after 1 year of PAP treatment
timeFrame: 1 year of PAP treatment
Secondary outcomes:
measure: Performance in Controlled Oral Word Association Test in untreated OSA patients compared to population norms.
timeFrame: 1 year of PAP treatment
measure: Performance in d2 Test in untreated OSA patients compared to population norms.
timeFrame: 1 year of PAP treatment
measure: Performance in Trail making test in untreated OSA patients compared to population norms.
timeFrame: 1 year of PAP treatment
measure: The difference between compliant and non-compliant patients in affective symptoms after 1 year follow up.
timeFrame: 1 year of PAP treatment
measure: The difference between compliant and non-compliant patients in anxiety symptoms after 1 year follow up.
timeFrame: 1 year of PAP treatment
measure: The difference between compliant and non-compliant patients in Controlled Oral Word Association Test after 1 year follow up.
timeFrame: 1 year of PAP treatment
measure: The difference between compliant and non-compliant patients in d2 Test after 1 year follow up.
timeFrame: 1 year of PAP treatment
measure: The difference between compliant and non-compliant patients in Trail making test after 1 year follow up.
timeFrame: 1 year of PAP treatment
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: University Hospital Olomouc
name: Jakub Vanek, MD.
role: STUDY_CHAIR
References:
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citation: Reichmuth KJ, Austin D, Skatrud JB, Young T. Association of sleep apnea and type II diabetes: a population-based study. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1590-5. doi: 10.1164/rccm.200504-637OC. Epub 2005 Sep 28.
citation: Hobzova M, Prasko J, Vanek J, Ociskova M, Genzor S, Holubova M, Grambal A, Latalova K. Depression and obstructive sleep apnea. Neuro Endocrinol Lett. 2017 Oct;38(5):343-352.
citation: Szaulinska K, Plywaczewski R, Sikorska O, Holka-Pokorska J, Wierzbicka A, Wichniak A, Sliwinski P. Obstructive sleep apnea in severe mental disorders. Psychiatr Pol. 2015;49(5):883-95. doi: 10.12740/PP/32566. English, Polish.
citation: Eikermann M, Jordan AS, Chamberlin NL, Gautam S, Wellman A, Lo YL, White DP, Malhotra A. The influence of aging on pharyngeal collapsibility during sleep. Chest. 2007 Jun;131(6):1702-9. doi: 10.1378/chest.06-2653. Epub 2007 Apr 5.
citation: Hobzova M, Hubackova L, Vanek J, Genzor S, Ociskova M, Grambal A, Prasko J. Cognitive function and depressivity before and after cpap treatment in obstructive sleep apnea patients. Neuro Endocrinol Lett. 2017 Jul;38(3):145-153.