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

Obstructive Sleep Apnea Clinical Trial

— QUOLOSA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02375321
• Other study ID #: Rubrica n. SPE 14.015
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 18, 2015
• Last updated: June 23, 2015
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2015
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 104
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Depressive Symptoms
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• CPAP and Psychological support
Six sessions of psychological support with cognitive behavioural orientation lasting 1 hour every two weeks for 3 months

Locations

Country	Name	City	State
Italy	Careggi Hospital - Terapia Intensiva Pneumologica	Firenze	Fi

Sponsors (1)

Lead Sponsor	Collaborator
Careggi Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No