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

NCT ID: NCT02375321

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-09-30

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".

Conditions

Obstructive Sleep Apnea; Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Study Group: patients with OSA and depressive symptoms treated with CPAP and psychological support

Group Type: EXPERIMENTAL

CPAP and Psychological support

Intervention Type: BEHAVIORAL

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

Group B

Control Group: patients with OSA and depressive symptoms treated with CPAP

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CPAP and Psychological support

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Careggi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Corrado Antonio, M. D

Chief of Respiratory Intensive Care Unit, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Corrado, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Careggi Hospital - Terapia Intensiva Pneumologica

Florence, Fi, Italy

Countries

Italy

References

Sampaioa R, Pereira MG, Winck JC. Psychological morbidity, illness representations, and quality of life in female and male patients with obstructive sleep apnea syndrome. Psychology, Health & Medicine 2 (17): 136-149, 2012 Akashiba T, Kawahara S, Akahoshi T, et al. Relationship Between Quality of Life and Mood or Depression in Patients With Severe Obstructive Sleep Apnea Syndrome. CHEST 122: 861-865, 2002 Glebocka A, Kossowska A, Bednarek M. Obstructive sleep apnea and the quality of life. Journal of Physiology and Pharmacology 57: 111-117, 2006 Diamanti C, Manali E, Ginieri-Coccossis M, et al. Depression, physical activity, energy consumption, and quality of life in OSA patients before and after CPAP treatment. Sleep Breath 17(4):1159-68, 2013 Gagnadoux F, Le Vaillant M, Goupil F, et al. Depressive symptoms before and after long-term continuous positive airway pressure therapy in sleep apnea patients. CHEST 145(5):1025-1031, 2014

Reference Type: BACKGROUND

Other Identifiers

Rubrica n. SPE 14.015

Identifier Type: -

Identifier Source: org_study_id