Type D Personality and the Compliance for CPAP Therapy and Cardiovascular Complications in OSA.

NCT04114409 | Unknown

• 1 other identifier: Slaaplabo protocol doc
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Academic Underachievement Disorder

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

1

OSAS and type D personality

2

OSAS without type D personality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients attending the sleeplaboratory

You may qualify if:

• 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

You may not qualify if:

• \- Age \< 18 years
• AHI\< 5/hour
• All patients incapable to understand the study or to sign the informed consent

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical physician

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 3, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 8, 2019

Record last verified: 2019-08