NCT03866161

The Effect of CPAP Treatment on Cognitive Functions, Anxiety, and Affective Symptoms

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital Olomouc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Continuous positive airway pressure	Continuous positive airway pressure treatment

Timeline

• Start date: 2019-02-15
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2019-03-07
• Last updated: 2022-11-02

Locations

1 site across 1 country: Czechia