Academic Underachievement Disorder Clinical Trial
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.
Verified date | August 2019 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | October 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - - Age < 18 years - AHI< 5/hour - All patients incapable to understand the study or to sign the informed consent |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Universitair Ziekenhuis Brussel |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4 years | |
Primary | 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 | 4 years | |
Primary | 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. | 4years | |
Primary | 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 | 4years |
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