Obstructive Sleep ApneaNCT03866161
The Effect of CPAP Treatment on Cognitive Functions, Anxiety, and Affective Symptoms
An observational study of Obstructive Sleep Apnea, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
Long term, prospective study of continuous positive airway pressure treatment influence on cognitive functions in patients with obstructive sleep apnea syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous positive airway pressure
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Feb 2019to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed obstructive sleep apnea indicated for positive airway pressure treatment
Who may be able to join
- Newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy, i.e. Apnea-Hypopnea index AHI> 15
Who cannot join
- Psychiatric treatment
- Treatment with psychoactive drugs
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Olomouc
Olomouc, 77900
Milan Sova, MD.,
About this study
Official title: The Effect of Positive Pressure Therapy (CPAP) in Patients With Obstructive Sleep Apnea on Cognitive Functions, Anxiety, and Affective Symptoms
Long term, prospective study of continuous positive airway pressure treatment influence on cognitive functions in patients with obstructive sleep apnea syndrome.
Read the 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
- Being tested
- Continuous positive airway pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Continuous positive airway pressure treatment
| Study group | Role | What they receive |
|---|---|---|
| CPAP group | Obstructive sleep apnea patients treated with continuous positive airway pressure Receives: Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year of PAP treatment
Secondary outcomes (8)
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.
Measured: 1 year of PAP treatment
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.
Measured: 1 year of PAP treatment
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.
Measured: 1 year of PAP treatment
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.
Measured: 1 year of PAP treatment
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.
Measured: 1 year of PAP treatment
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.
Measured: 1 year of PAP treatment
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.
Measured: 1 year of PAP treatment
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.
Measured: 1 year of PAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start15 Feb 2019
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milan Sova, University Hospital Olomouc
- Investigators
- Jakub Vanek, MD., Study chair, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866161
- Sponsor's protocol ID
- OSAS_CPAP_CF
- Status last verified
- Nov 2022
- First submitted
- 18 Feb 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10927725Reichmuth 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.
PubMed 16192452Hobzova 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.
PubMed 29106789Szaulinska 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.
PubMed 26688840Eikermann 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.
PubMed 17413053Hobzova 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.
PubMed 28759181Vanek 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.
PubMed 37366480
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Positive Pressure Therapy (CPAP) in Patients With Obstructive Sleep Apnea on Cognitive Functions, Anxiety, and Affective Symptoms
- ClinicalTrials.gov ID
- NCT03866161
- Acronym / sponsor ID
- OSAS_CPAP_CF
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP group | – | Device: Continuous positive airway pressureObstructive sleep apnea patients treated with continuous positive airway pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed obstructive sleep apnea indicated for positive airway pressure treatment
Key inclusion criteria (1 listed)
- Newly diagnosed obstructive sleep apnea indicated for positive airway pressure therapy, i.e. Apnea-Hypopnea index AHI> 15
Key exclusion criteria (2 listed)
- Psychiatric treatment
- Treatment with psychoactive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous positive airway pressureContinuous positive airway pressure treatment | Device | CPAP group |
Primary outcome
Change of affective symptoms after 1 year of PAP treatment
Time frame: 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
Time frame: 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 Controlled Oral Word Association Test after 1 year of PAP treatment
Time frame: 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.
Change in d2 Test after 1 year of PAP treatment
Time frame: 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 in Trail making test after 1 year of PAP treatment
Time frame: 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.
8 secondary outcomes
Performance in Controlled Oral Word Association Test in untreated OSA patients compared to population norms.
Time frame: 1 year of PAP treatment
Performance in d2 Test in untreated OSA patients compared to population norms.
Time frame: 1 year of PAP treatment
Performance in Trail making test in untreated OSA patients compared to population norms.
Time frame: 1 year of PAP treatment
The difference between compliant and non-compliant patients in affective symptoms after 1 year follow up.
Time frame: 1 year of PAP treatment
The difference between compliant and non-compliant patients in anxiety symptoms after 1 year follow up.
Time frame: 1 year of PAP treatment
The difference between compliant and non-compliant patients in Controlled Oral Word Association Test after 1 year follow up.
Time frame: 1 year of PAP treatment
The difference between compliant and non-compliant patients in d2 Test after 1 year follow up.
Time frame: 1 year of PAP treatment
The difference between compliant and non-compliant patients in Trail making test after 1 year follow up.
Time frame: 1 year of PAP treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Results publication: PubMed 10927725Bixler 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.
- Results publication: PubMed 16192452Reichmuth 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.
- Results publication: PubMed 29106789Hobzova 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.
- Results publication: PubMed 26688840Szaulinska 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.
- Results publication: PubMed 17413053Eikermann 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.
- Results publication: PubMed 28759181Hobzova 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.
- Derived from this study: PubMed 37366480Vanek 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakub Vanek, MD. study chair
University Hospital Olomouc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milan Sova, MD, Ph.D. (+420588445326, milan.sova@fnol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of affective symptoms after 1 year of PAP treatment (time frame: 1 year of PAP treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03866161, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.