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

NCT03866161 | Unknown

• 1 other identifier: OSAS_CPAP_CF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Performance in Controlled Oral Word Association Test in untreated OSA patients compared to population norms.

  1 year of PAP treatment

• Performance in d2 Test in untreated OSA patients compared to population norms.

  1 year of PAP treatment

• 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 anxiety symptoms after 1 year follow up.

  1 year of PAP treatment

Study Arms (1)

CPAP group

Obstructive sleep apnea patients treated with continuous positive airway pressure

Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressure DEVICE

Continuous positive airway pressure treatment

CPAP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with newly diagnosed obstructive sleep apnea indicated for positive airway pressure treatment

You may qualify if:

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

You may not qualify if:

• Psychiatric treatment
• Treatment with psychoactive drugs

Sponsors & Collaborators

• University Hospital Olomouc: lead

Study Sites (1)

University Hospital Olomouc

Olomouc, 77900, Czechia

RECRUITING

Related Publications (7)

• 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. doi: 10.1001/archinte.160.15.2289.

  PMID: 10927725 RESULT

• 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.

  PMID: 16192452 RESULT

• 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.

  PMID: 29106789 RESULT

• 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.

  PMID: 26688840 RESULT

• 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.

  PMID: 17413053 RESULT

• 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.

  PMID: 28759181 RESULT

• Vanek J, Prasko J, Genzor S, Belohradova K, Visnovsky J, Mizera J, Bocek J, Sova M, Ociskova M. Cognitive Functions, Depressive and Anxiety Symptoms After One Year of CPAP Treatment in Obstructive Sleep Apnea. Psychol Res Behav Manag. 2023 Jun 21;16:2253-2266. doi: 10.2147/PRBM.S411465. eCollection 2023.

  PMID: 37366480 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Jakub Vanek, MD.

  University Hospital Olomouc

  STUDY CHAIR

Central Study Contacts

Milan Sova, MD, Ph.D.

CONTACT

+420588445326; milan.sova@fnol.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Sleep laboratory, Department of Respiratory Medicine

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: March 7, 2019
• Study Start: February 15, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 2, 2022

Record last verified: 2022-11

Locations

CZ (1)