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Quality of Life in Patients With Obstructive Sleep Apnea: The Role of CPAP Associated to Psychological Support

Quality of Life in Patients With Obstructive Sleep Apnea: The Role of CPAP Associated to Psychological Support

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02375321
Acronym
QUOLOSA
Enrollment
104
Registered
2015-03-02
Start date
2014-05-31
Completion date
2016-09-30
Last updated
2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms, Obstructive Sleep Apnea

Keywords

OSA, Depression, Quality of Life, CPAP

Brief summary

Many researches have shown that patients with Obstructive Sleep Apnea (OSA) and often also the family members have a decreased quality of life, problems related to the sexual sphere, depressive disorders and anxiety problems. To date still remains controversial the relationship between OSA and quality of life, also the link between sleep apnea syndrome and depression is unclear. In adult patients with OSA the treatment of choice is the application of a continuous positive airway pressure (CPAP: Continuous Positive Airway Pressure) at the opening of the airways. With the CPAP treatment the sleep normalizes and daytime sleepiness fades or disappears. Many studies have shown that this treatment determines improvement of the medical and psychological status. However, the rate of non-adherence to treatment reported in the literature is about 46-83%, considering as adherence the use of CPAP for at least 4 hours per night. A recent study has shown that CPAP used as a single treatment in patients with OSA and depression, has reduced the depressive symptoms but in a significant percentage of patients (42%), the depressive symptoms remained unchanged or worsened. At the present time have not been published, to our knowledge, studies concerning the effectiveness of the combined treatment of CPAP and psychological support on the mood and on the quality of life OSA patients. Therefore the aim of this study is to evaluate the effects of the combined treatment with CPAP and psychological intervention with cognitive behavioural therapy on the mood and on the quality of life of OSA patients.

Detailed description

Primary endpoint The primary endpoint of the study is the evaluation of the mood tone, measured before and 12 weeks after the start of treatment through the administration of the13-item self-rated Pichot depression scale (QD2A). Each subject will be assigned to one of the following categories:absence of alterations in mood or presence of mood disorders, according to the test result (score \<7 or score ≥7). The subjects in which, for whatever reason, the QD2A test after 12 weeks of treatment will not be available, will be considered failures, and will be assigned to the class presence of mood disorders. Secondary endpoint Evaluation of adherence to CPAP treatment, considering as adherence the use of CPAP, during the observation period, for at least 4 hours per night. After 12 weeks of treatment, each patient will be classified as adherent or non-adherent to the treatment itself. The subjects in whom, for whatever reason, after 12 weeks of treatment, the total number of hours of use of CPAP will not be available, will be assigned to the class of non-adherent.

Interventions

BEHAVIORALCPAP and Psychological support

Six sessions of psychological support with cognitive behavioural orientation lasting 1 hour every two weeks for 3 months

Sponsors

Careggi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* all patients with a known diagnosis of obstructive sleep apnea who need of treatment with CPAP * aged 18-70 years * presence of alteration of mood, identified by a score of ≥7 by means the QD2A test * written informed consent, signed and dated

Exclusion criteria

* previous treatment for OSA * sleep disorders different from OSA * cognitive impairment diseases * severe psychiatric disorders * alcoholism or other abuses.

Design outcomes

Primary

MeasureTime frame
The difference between the proportion of subjects with no alterations of mood, measured by means of the QD2A test, before and 12 weeks after the start of treatment, observed in the CPAP group plus psychological support and only CPAP treatment3 months

Secondary

MeasureTime frame
The difference between the proportion of subjects adherent to CPAP treatment in both groups, considering as adherence the use of CPAP, during the observation period, for at least 4 hours per night.3 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026