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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea; Depressive Symptoms
• Intervention / Treatment: Behavioral: CPAP and Psychological support

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".

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Fi
    • Firenze, Fi, Italy, 50134
      • Careggi Hospital - Terapia Intensiva Pneumologica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Study Group: patients with OSA and depressive symptoms treated with CPAP and psychological support	Behavioral: CPAP and Psychological support; Six sessions of psychological support with cognitive behavioural orientation lasting 1 hour every two weeks for 3 months
No Intervention: Group B; Control Group: patients with OSA and depressive symptoms treated with CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 treatment	3 months

Secondary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: Careggi Hospital
• Investigators: Principal Investigator: Antonio Corrado, MD

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; OSA; CPAP
• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Depression; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: Rubrica n. SPE 14.015