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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03866161
• Other study ID #: OSAS_CPAP_CF
• Status: Recruiting
• Start date: February 15, 2019
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2022
• Source: University Hospital Olomouc
• Contact: Milan Sova, MD, Ph.D.
• Phone: +420588445326
• Email: milan.sova[@]fnol.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Affective Symptoms
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous positive airway pressure
Continuous positive airway pressure treatment

Locations

Country	Name	City	State
Czechia	University Hospital Olomouc	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

References & Publications (6)

Bixler EO, Vgontzas AN, Lin HM, Ten Have T, Leiby BE, Vela-Bueno A, Kales A. Association of hypertension and sleep-disordered breathing. Arch Intern Med. 2000 Aug 14-28;160(15):2289-95. — View 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. Epub 2007 Apr 5. — View 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. — View 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. Review. — View 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. Epub 2005 Sep 28. — View 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. Review. English, Polish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of affective symptoms after 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.	1 year of PAP treatment
Primary	Change of anxiety symptoms after 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.	1 year of PAP treatment
Primary	Change in Controlled Oral Word Association Test after 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.	1 year of PAP treatment
Primary	Change in d2 Test after 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.	1 year of PAP treatment
Primary	Change in Trail making test after 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.	1 year of PAP treatment
Secondary	Performance in Controlled Oral Word Association Test in untreated OSA patients compared to population norms.	The results of Controlled Oral Word Association Test in OSA patients before PAP treatment will be compared with population norms to assess the cognitive impairment in untreated OSA patients.; 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.	1 year of PAP treatment
Secondary	Performance in d2 Test in untreated OSA patients compared to population norms.	The results of d2 Test in OSA patients before PAP treatment will be compared with population norms to assess the cognitive impairment in untreated OSA patients.; 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.	1 year of PAP treatment
Secondary	Performance in Trail making test in untreated OSA patients compared to population norms.	The results of Trail making test in OSA patients before PAP treatment will be compared with population norms to assess the cognitive impairment in untreated OSA patients.; 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.	1 year of PAP treatment
Secondary	The difference between compliant and non-compliant patients in affective symptoms after 1 year follow up.	Statistically significant difference in the scores of Beck Depression Inventory in compliant (at least 4 hours of PAP treatment per night) and non-compliant patients (less than 4 hours of PAP treatment per night on average) after 1 year of follow up.; 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.	1 year of PAP treatment
Secondary	The difference between compliant and non-compliant patients in anxiety symptoms after 1 year follow up.	Statistically significant difference in the scores of Beck Anxiety Inventory in compliant (at least 4 hours of PAP treatment per night) and non-compliant patients (less than 4 hours of PAP treatment per night on average) after 1 year of follow up.; The total score is calculated by finding the 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.	1 year of PAP treatment
Secondary	The difference between compliant and non-compliant patients in Controlled Oral Word Association Test after 1 year follow up.	Statistically significant difference in the scores of Controlled Oral Word Association Test in compliant (at least 4 hours of PAP treatment per night) and non-compliant patients (less than 4 hours of PAP treatment per night on average) after 1 year of follow up.; 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.	1 year of PAP treatment
Secondary	The difference between compliant and non-compliant patients in d2 Test after 1 year follow up.	Statistically significant difference in the scores of d2 Test in compliant (at least 4 hours of PAP treatment per night) and non-compliant patients (less than 4 hours of PAP treatment per night on average) after 1 year of follow up.; 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.	1 year of PAP treatment
Secondary	The difference between compliant and non-compliant patients in Trail making test after 1 year follow up.	Statistically significant difference in the scores of Trail making test in compliant (at least 4 hours of PAP treatment per night) and non-compliant patients (less than 4 hours of PAP treatment per night on average) after 1 year of follow up.; 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.	1 year of PAP treatment