Academic Underachievement DisorderNCT04114409
Type D Personality and the Compliance for CPAP Therapy and Cardiovascular Complications in OSA.
An observational study of Academic Underachievement Disorder, run by Universitair Ziekenhuis Brussel.
Trial summary
Type D personality is characterized by negative affectivity and social inhibition and is assessed with the DS-14 questionnaire. This type of personality was initially described in patients with coronary heart disease and associated with poor prognosis and diminished quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Academic Underachievement Disorder
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Oct 2023
- How long will I take part?
- 1 Year
- 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
- Adult, Older adult
Study population: All patients attending the sleeplaboratory
Who may be able to join
- All patients with an OSA (AHI (Apnea-hypopnea index) >5/hour) and type D personality (DS- 14 score: SI (social inhibition) >10 and NA (negative affectivity) >10)
- Age > 18 years
Who cannot join
- - Age < 18 years
- AHI< 5/hour
- All patients incapable to understand the study or to sign the informed consent
About this study
Official title: The Prevalence of Type D Personality in OSAS and the CPAP Therapy Compliance and Cardiovascular Complications in Moderate to Severe OSAS With Type D Personality.
Type D personality is characterized by negative affectivity and social inhibition and is assessed with the DS-14 questionnaire. This type of personality was initially described in patients with coronary heart disease and associated with poor prognosis and diminished quality of life. Whereas the prevalence of type D personality in patients with coronary heart disease is between 27% and 31%, the prevalence in the general population is between 13% and 24%. The prevalence of type D personality in OSA (Obstructive Sleep Apnea Syndrome) was only investigated in patients with a moderate or severe OSA (Apnea-hypopnea index > 15/hour) already on standard clinical treatment with CPAP (Continuous Positive Airway Pressure). The overall prevalence of type D personality in OSA is still unknown. Furthermore, OSA is frequently associated with cardiovascular disease. No studies were performed on the impact of type D personality and cardiovascular complications in OSA.
Until now, only a few studies were performed to investigate type D personality in OSA patients treated with CPAP therapy. One retrospective study showed that OSA patients with type D personality experienced more side effects of CPAP treatment and were less compliant to therapy. In a more recent prospective study, the influence of type D personality on CPAP compliance could not be confirmed. No information is available about the frequency of visits and the time spent by these patients to remediate CPAP side effects. There is also no data about the discontinuation rate of CPAP treatment in this population of patients. It is possible that a specific follow up of those patients is needed to enhance CPAP compliance.
Read more
After a while, CPAP therapy can have an influence on mood and behavior. Therefore, it is possible that CPAP therapy can alter the patient's answers to the DS-14 questionnaire. This could explain the different outcome of the retrospective and prospective studies mentioned above. No studies were performed to test the reliability and validate the DS-14 questionnaire in OSA patients.
Consequently, the aim of the present study is to evaluate more extensively the importance of type D personality traits in OSA patients.
Read the detailed description
Objective of the study
- To determine the overall prevalence of type D personality in untreated OSA ( Obstructive sleep apnea) patients and their subtypes; mild, moderate, severe and REM (rapid eye movement) OSA. Full polysomnography and questionnaires:ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS will be used to answer this question. A multistage tracking for gender and type D personality was done. In general population, there are twice as much men than women suffering from OSA. This means that the investigator need to recruit 41% (√ 2 ≈ 1.41%) more men than women. In the general population, the prevalence of type D personality is 25%. To answer this question, the investigator also assume that there will be 50 % mild, 25% moderate and 25% severe OSA. Chi- squared test: With a power of 0.9: 97 type D patients are needed with a total of 400 patients to be recruited.
- To establish the reliability and validity of the DS-14 questionnaire to diagnose type D personality in OSA patients. Full polysomnography and questionnaires:ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS will be used. the DS-14 questionnaire will be filled out one month later. An interclass correlation analysis with kappa ≈ 0.8 will give a good correlation between the two scores. First, a pilot study will be done on a small sample of patients. In function of these results, a sample calculation required to have a significant result will be done. In an earlier study, 135 patients with type D personality were studied to assess the reproducibility of the DS-14 questionnaire.
- To investigate the impact of type D personality on CPAP ( continuous positive airway pressure) treatment in OSA patients, especially on compliance for CPAP, on the CPAP discontinuation rate and on the frequency and time spent to remediate side effects of CPAP treatment. Full polysomnography and questionnaires:ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS will be used. The DS-14 questionnaire will be filled out one month later.Titration polysomnography 2 months later and questionnaires: ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, CIS.Consultation 3 month later for control compliance and questionnaires: DS-14, SF-36, HADS, FAS, CIS, EES, PSQI.Polyclinic visit 1 year later for control compliance and questionnaires: DS-14, SF-36, HADS, FAS, CIS, EES, PSQI.Monitoring time and frequency of free consultation for resolving any side effects of the CPAP treatment. Additionally, the investigator assume that there is a 25% chance (midrange) to discontinue CPAP treatment and 70% (midrange) compliance. Compliance will be normalized to a percentage scale by dividing by the expected hours of sleep (for the power analysis, we take 7 hours expected sleep). A hypothetical difference of 1 hour will therefore represent 14.29% (=1/7). For the t-tests: Standard deviation: based on a 95% interval for CPAP [4h-9h], the investigator divide this interval of 5 h by 4 (4 sigma's for 95%). Followed by a normalization (1/7), one sigma gives 17.86%. With a power of 0.9 and α= 0.01 (Bonferonni correction), 128 patients will be needed for an unbalanced design of both groups in a ratio of 75% versus 25%. For the Fisher Exact- test: General OSA population Expected in type D Good compliance 70% (between 60 \& 80%) 56% ( 70% minus 14%) Poor compliance 30% 44% With a power of 0.9: in total 580 patients are needed. (580 patients of which 25% type D: Feasible since about 500 new OSA patients are diagnosed and treated a year at the UZ Brussels)
- To determine the influence of type D personality on cardiovascular complications in OSA.
Baseline polysomnography: two groups: OSA with type D and without type D and questionnaires: ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS. Search medical files for cardiovascular morbidity in both groups Additionally, the investigator assume that there is a 25% chance (midrange) to discontinue CPAP treatment and 70% (midrange) compliance. Compliance will be normalized to a percentage scale by dividing by the expected hours of sleep (for the power analysis, we take 7 hours expected sleep). A hypothetical difference of 1 hour will therefore represent 14.29% (=1/7).
For the t-tests:
Standard deviation: based on a 95% interval for CPAP [4h-9h], the investigator divide this interval of 5 h by 4 (4 sigma's for 95%). Followed by a normalization (1/7), one sigma gives 17.86%. With a power of 0.9 and α= 0.01 (Bonferonni correction), 128 patients will be needed for an unbalanced design of both groups in a ratio of 75% versus 25%.
For the Fisher Exact- test:
General OSA population Expected in type D Good compliance 70% (between 60 \& 80%) 56% ( 70% minus 14%) Poor compliance 30% 44%
With a power of 0.9: in total 580 patients are needed. (580 patients of which 25% type D: Feasible since about 500 new OSA patients are diagnosed and treated a year at the UZ Brussels)
Procedures To determine the overall prevalence of type D personality in untreated OSA patients and their subtypes, all patients admitted to the sleep laboratory for a polysomnography will be asked to participate to this study. An informed consent will be signed and patients will complete a number of questionnaires. In the current practice of the sleep laboratory, the Epworth sleepiness scale, the Stanford sleepiness scale, the Pittsburgh sleep quality index, the Insomnia severity scale, the DS-14 questionnaire, the SF-36 questionnaire, the FAS, HADS, BFI-2 and CIS are filled out by each patient.
All patients who test positive for OSA (AHI > 5/hour) and positive for type D personality (DS-14: SI>10 and NA>10) will be asked to complete these questionnaires once more 1 month later. This is necessary to evaluate the test-retest reliability/stability of the DS-14 questionnaire in OSA. To evaluate the validity of this questionnaire in OSA, correlation patterns with the BFI-2 and the HADS will be investigated.
For all patients diagnosed with moderate OSA in which treatment with CPAP is indicated, the questionnaires will be repeated during their second polysomnography (standard of care), 3 months after the second polysomnography (standard of care) and 1 year after this last visit (standard of care). The second polysomnography is needed to estimate the therapeutic pressure and to meet the criteria for the OSA convention. The time necessary for treatment education (time to explain function of CPAP), frequency of visits and time necessary to deal with complications, treatment compliance (hours of use CPAP device), treatment discontinuation will be monitored. The group with OSA and type D personality will be compared with the OSA group without type D personality.
A search for cardiovascular events in the electronic medical file of all OSA patients with and without type D personality will be carried out.
The above mentioned procedures will all be carried out in the sleep laboratory of the UZ Brussel, Laarbeeklaan 101, 1090 Jette.
- Conditions
- Academic Underachievement Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | OSAS and type D personality | |
| 2 | OSAS without type D personality |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall prevalence of type D personality in untreated OSA ( Obstructive sleep apnea) patients and their subtypes; mild, moderate, severe and REM (rapid eye movement) OSA.
The prevalence of type D personality in the different types of OSA wil be statistically calculated after scoring the DS-14 questionnaire as wel as other questionnaires, ESS, PSQI, SF-36, ISI, FAS, HADS, BFI-2, CIS. These questionaires will be filled out by the population patients refered to the sleeplaboratory for a full polysomnography.
Measured: 4 years
The reliability and validity of the DS-14 questionnaire to diagnose type D personality in OSA patients.
The DS-14 questionnaire, filled out at baseline polysomnography will be repeated 1 month later and the scores will be compared by an interclass correlation analysis. This is necessary for the reliability. For the validity of the questionnaire, a correlation between the BFI-2 will be necessary
Measured: 4 years
the impact of type D personality on CPAP ( continuous positive airway pressure) treatment in OSA patients on compliance for CPAP, CPAP discontinuation rate and frequency and time spent to remediate side effects of CPAP treatment.
The questionnaires, ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS, filled out at baseline polysomnography will be repeated during the titration night ( night necessary to evaluate pressure and for the convention OSA). During the different required visits , some of these questionnaires will be repeated ( see above). The scores of these questionnaires will be compared during CPAP therapy. The compliance of therapy ( registrated automatically by the CPAP devise) will be compared between two groups, OSA + type D and OSA without type D. The time spend for education of the use of the cpap, the time necessary to solve complication of therapy and the frequency of visits to the sleeplaboratory of the patients in both groups will be recorded and compared. Allso the discontinuation of cpap therapy will be compared in both groups.
Measured: 4years
To determine the influence of type D personality on cardiovascular complications in OSA.
In both groups (OSA+ type D and OSA without type D) a search in the medical file for cardiovascular events in the history will be done by recording arythmias, hypertension, cerebrovascular accident. The results will be compared between the two groups
Measured: 4years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Academic Underachievement DisorderStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia De Weerdt, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114409
- Sponsor's protocol ID
- Slaaplabo protocol doc
- Status last verified
- Aug 2019
- First submitted
- 30 Sep 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Type D Personality in OSAS and the CPAP Therapy Compliance and Cardiovascular Complications in Moderate to Severe OSAS With Type D Personality.
- ClinicalTrials.gov ID
- NCT04114409
- Acronym / sponsor ID
- Slaaplabo protocol doc
- Conditions
- Academic Underachievement Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 3 Oct 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.
Type D personality is characterized by negative affectivity and social inhibition and is assessed with the DS-14 questionnaire. This type of personality was initially described in patients with coronary heart disease and associated with poor prognosis and diminished quality of life. Whereas the prevalence of type D personality in patients with coronary heart disease is between 27% and 31%, the prevalence in the general population is between 13% and 24%. The prevalence of type D personality in OSA (Obstructive Sleep Apnea Syndrome) was only investigated in patients with a moderate or severe OSA (Apnea-hypopnea index > 15/hour) already on standard clinical treatment with CPAP (Continuous Positive Airway Pressure). The overall prevalence of type D personality in OSA is still unknown. Furthermore, OSA is frequently associated with cardiovascular disease. No studies were performed on the impact of type D personality and cardiovascular complications in OSA.
Until now, only a few studies were performed to investigate type D personality in OSA patients treated with CPAP therapy. One retrospective study showed that OSA patients with type D personality experienced more side effects of CPAP treatment and were less compliant to therapy. In a more recent prospective study, the influence of type D personality on CPAP compliance could not be confirmed. No information is available about the frequency of visits and the time spent by these patients to remediate CPAP side effects. There is also no data about the discontinuation rate of CPAP treatment in this population of patients. It is possible that a specific follow up of those patients is needed to enhance CPAP compliance.
After a while, CPAP therapy can have an influence on mood and behavior. Therefore, it is possible that CPAP therapy can alter the patient's answers to the DS-14 questionnaire. This could explain the different outcome of the retrospective and prospective studies mentioned above. No studies were performed to test the reliability and validate the DS-14 questionnaire in OSA patients.
Consequently, the aim of the present study is to evaluate more extensively the importance of type D personality traits in OSA patients.
Detailed description
Objective of the study
- To determine the overall prevalence of type D personality in untreated OSA ( Obstructive sleep apnea) patients and their subtypes; mild, moderate, severe and REM (rapid eye movement) OSA. Full polysomnography and questionnaires:ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS will be used to answer this question. A multistage tracking for gender and type D personality was done. In general population, there are twice as much men than women suffering from OSA. This means that the investigator need to recruit 41% (√ 2 ≈ 1.41%) more men than women. In the general population, the prevalence of type D personality is 25%. To answer this question, the investigator also assume that there will be 50 % mild, 25% moderate and 25% severe OSA. Chi- squared test: With a power of 0.9: 97 type D patients are needed with a total of 400 patients to be recruited.
- To establish the reliability and validity of the DS-14 questionnaire to diagnose type D personality in OSA patients. Full polysomnography and questionnaires:ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS will be used. the DS-14 questionnaire will be filled out one month later. An interclass correlation analysis with kappa ≈ 0.8 will give a good correlation between the two scores. First, a pilot study will be done on a small sample of patients. In function of these results, a sample calculation required to have a significant result will be done. In an earlier study, 135 patients with type D personality were studied to assess the reproducibility of the DS-14 questionnaire.
- To investigate the impact of type D personality on CPAP ( continuous positive airway pressure) treatment in OSA patients, especially on compliance for CPAP, on the CPAP discontinuation rate and on the frequency and time spent to remediate side effects of CPAP treatment. Full polysomnography and questionnaires:ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS will be used. The DS-14 questionnaire will be filled out one month later.Titration polysomnography 2 months later and questionnaires: ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, CIS.Consultation 3 month later for control compliance and questionnaires: DS-14, SF-36, HADS, FAS, CIS, EES, PSQI.Polyclinic visit 1 year later for control compliance and questionnaires: DS-14, SF-36, HADS, FAS, CIS, EES, PSQI.Monitoring time and frequency of free consultation for resolving any side effects of the CPAP treatment. Additionally, the investigator assume that there is a 25% chance (midrange) to discontinue CPAP treatment and 70% (midrange) compliance. Compliance will be normalized to a percentage scale by dividing by the expected hours of sleep (for the power analysis, we take 7 hours expected sleep). A hypothetical difference of 1 hour will therefore represent 14.29% (=1/7). For the t-tests: Standard deviation: based on a 95% interval for CPAP [4h-9h], the investigator divide this interval of 5 h by 4 (4 sigma's for 95%). Followed by a normalization (1/7), one sigma gives 17.86%. With a power of 0.9 and α= 0.01 (Bonferonni correction), 128 patients will be needed for an unbalanced design of both groups in a ratio of 75% versus 25%. For the Fisher Exact- test: General OSA population Expected in type D Good compliance 70% (between 60 \& 80%) 56% ( 70% minus 14%) Poor compliance 30% 44% With a power of 0.9: in total 580 patients are needed. (580 patients of which 25% type D: Feasible since about 500 new OSA patients are diagnosed and treated a year at the UZ Brussels)
- To determine the influence of type D personality on cardiovascular complications in OSA.
Baseline polysomnography: two groups: OSA with type D and without type D and questionnaires: ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS. Search medical files for cardiovascular morbidity in both groups Additionally, the investigator assume that there is a 25% chance (midrange) to discontinue CPAP treatment and 70% (midrange) compliance. Compliance will be normalized to a percentage scale by dividing by the expected hours of sleep (for the power analysis, we take 7 hours expected sleep). A hypothetical difference of 1 hour will therefore represent 14.29% (=1/7).
For the t-tests:
Standard deviation: based on a 95% interval for CPAP [4h-9h], the investigator divide this interval of 5 h by 4 (4 sigma's for 95%). Followed by a normalization (1/7), one sigma gives 17.86%. With a power of 0.9 and α= 0.01 (Bonferonni correction), 128 patients will be needed for an unbalanced design of both groups in a ratio of 75% versus 25%.
For the Fisher Exact- test:
General OSA population Expected in type D Good compliance 70% (between 60 \& 80%) 56% ( 70% minus 14%) Poor compliance 30% 44%
With a power of 0.9: in total 580 patients are needed. (580 patients of which 25% type D: Feasible since about 500 new OSA patients are diagnosed and treated a year at the UZ Brussels)
Procedures To determine the overall prevalence of type D personality in untreated OSA patients and their subtypes, all patients admitted to the sleep laboratory for a polysomnography will be asked to participate to this study. An informed consent will be signed and patients will complete a number of questionnaires. In the current practice of the sleep laboratory, the Epworth sleepiness scale, the Stanford sleepiness scale, the Pittsburgh sleep quality index, the Insomnia severity scale, the DS-14 questionnaire, the SF-36 questionnaire, the FAS, HADS, BFI-2 and CIS are filled out by each patient.
All patients who test positive for OSA (AHI > 5/hour) and positive for type D personality (DS-14: SI>10 and NA>10) will be asked to complete these questionnaires once more 1 month later. This is necessary to evaluate the test-retest reliability/stability of the DS-14 questionnaire in OSA. To evaluate the validity of this questionnaire in OSA, correlation patterns with the BFI-2 and the HADS will be investigated.
For all patients diagnosed with moderate OSA in which treatment with CPAP is indicated, the questionnaires will be repeated during their second polysomnography (standard of care), 3 months after the second polysomnography (standard of care) and 1 year after this last visit (standard of care). The second polysomnography is needed to estimate the therapeutic pressure and to meet the criteria for the OSA convention. The time necessary for treatment education (time to explain function of CPAP), frequency of visits and time necessary to deal with complications, treatment compliance (hours of use CPAP device), treatment discontinuation will be monitored. The group with OSA and type D personality will be compared with the OSA group without type D personality.
A search for cardiovascular events in the electronic medical file of all OSA patients with and without type D personality will be carried out.
The above mentioned procedures will all be carried out in the sleep laboratory of the UZ Brussel, Laarbeeklaan 101, 1090 Jette.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –OSAS and type D personality |
| 2 | – | –OSAS without type D personality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients attending the sleeplaboratory
Key inclusion criteria (2 listed)
- All patients with an OSA (AHI (Apnea-hypopnea index) >5/hour) and type D personality (DS- 14 score: SI (social inhibition) >10 and NA (negative affectivity) >10)
- Age > 18 years
Key exclusion criteria (3 listed)
- - Age < 18 years
- AHI< 5/hour
- All patients incapable to understand the study or to sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The overall prevalence of type D personality in untreated OSA ( Obstructive sleep apnea) patients and their subtypes; mild, moderate, severe and REM (rapid eye movement) OSA.
Time frame: 4 years
The prevalence of type D personality in the different types of OSA wil be statistically calculated after scoring the DS-14 questionnaire as wel as other questionnaires, ESS, PSQI, SF-36, ISI, FAS, HADS, BFI-2, CIS. These questionaires will be filled out by the population patients refered to the sleeplaboratory for a full polysomnography.
The reliability and validity of the DS-14 questionnaire to diagnose type D personality in OSA patients.
Time frame: 4 years
The DS-14 questionnaire, filled out at baseline polysomnography will be repeated 1 month later and the scores will be compared by an interclass correlation analysis. This is necessary for the reliability. For the validity of the questionnaire, a correlation between the BFI-2 will be necessary
the impact of type D personality on CPAP ( continuous positive airway pressure) treatment in OSA patients on compliance for CPAP, CPAP discontinuation rate and frequency and time spent to remediate side effects of CPAP treatment.
Time frame: 4years
The questionnaires, ESS, PSQI, DS-14, SF-36, ISI, FAS, HADS, BFI-2, CIS, filled out at baseline polysomnography will be repeated during the titration night ( night necessary to evaluate pressure and for the convention OSA). During the different required visits , some of these questionnaires will be repeated ( see above). The scores of these questionnaires will be compared during CPAP therapy. The compliance of therapy ( registrated automatically by the CPAP devise) will be compared between two groups, OSA + type D and OSA without type D. The time spend for education of the use of the cpap, the time necessary to solve complication of therapy and the frequency of visits to the sleeplaboratory of the patients in both groups will be recorded and compared. Allso the discontinuation of cpap therapy will be compared in both groups.
To determine the influence of type D personality on cardiovascular complications in OSA.
Time frame: 4years
In both groups (OSA+ type D and OSA without type D) a search in the medical file for cardiovascular events in the history will be done by recording arythmias, hypertension, cerebrovascular accident. The results will be compared between the two groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Academic Underachievement Disorder, run by Universitair Ziekenhuis Brussel.
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 2 inclusion and 3 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall prevalence of type D personality in untreated OSA ( Obstructive sleep apnea) patients and their subtypes; mild, moderate, severe and REM (rapid eye movement) OSA. (time frame: 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2019.