Obstructive Sleep ApneaQUOLOSANCT02375321
Quality of Life in Patients With Obstructive Sleep Apnea: The Role of CPAP Associated to Psychological Support
A study testing CPAP and Psychological support in people with Obstructive Sleep Apnea and Depressive Symptoms, run by Careggi Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Depressive Symptoms
- What is being tested?
- CPAP and Psychological support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- May 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous treatment for OSA
- sleep disorders different from OSA
- cognitive impairment diseases
- severe psychiatric disorders
- alcoholism or other abuses.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Careggi Hospital - Terapia Intensiva Pneumologica
Florence, Fi, 50134
About this study
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.
Read more
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.
Read the 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
- Being tested
- CPAP and Psychological support
- Keywords
- OSA, Depression, Quality of Life, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP and Psychological supportBehavioural
Six sessions of psychological support with cognitive behavioural orientation lasting 1 hour every two weeks for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Study Group: patients with OSA and depressive symptoms treated with CPAP and psychological support Receives: Behavioral: CPAP and Psychological support |
| Group B | No intervention | Control Group: patients with OSA and depressive symptoms treated with CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corrado Antonio, M. D, Careggi Hospital
- Investigators
- Antonio Corrado, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375321
- Sponsor's protocol ID
- Rubrica n. SPE 14.015
- Acronym
- QUOLOSA
- Status last verified
- Jun 2015
- First submitted
- 18 Feb 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients With Obstructive Sleep Apnea: The Role of CPAP Associated to Psychological Support
- ClinicalTrials.gov ID
- NCT02375321
- Acronym / sponsor ID
- QUOLOSA / Rubrica n. SPE 14.015
- Conditions
- Obstructive Sleep Apnea, Depressive Symptoms
- Keywords
- OSA, Depression, Quality of Life, CPAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Behavioral: CPAP and Psychological supportStudy Group: patients with OSA and depressive symptoms treated with CPAP and psychological support |
| Group B | No intervention | –Control Group: patients with OSA and depressive symptoms treated with CPAP |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- previous treatment for OSA
- sleep disorders different from OSA
- cognitive impairment diseases
- severe psychiatric disorders
- alcoholism or other abuses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP and Psychological supportSix sessions of psychological support with cognitive behavioural orientation lasting 1 hour every two weeks for 3 months | Behavioural | Group A |
Primary outcome
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
Time frame: 3 months
1 secondary outcome
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.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- BackgroundSampaioa 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Corrado, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and Psychological support in people with Obstructive Sleep Apnea and Depressive Symptoms, run by Careggi Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02375321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.