Obstructive Sleep Apnea
Conditions
Brief summary
This study is aimed to evaluate whether the information provided by health care professionals in the visits previous to start with CPAP treatment may influence the number of reported adverse effects and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP.
Detailed description
Background: The presence of side effects in the first few weeks of treatment with CPAP is common. However, it has never been evaluated whether side effects could be related to the presence of the nocebo effect in this population. Main objective: To assess whether the information provided by health care professionals may influence the number of reported adverse events and compliance in patients with obstructive sleep apnea (OSA) in treatment with CPAP. Methodology: Unicentric randomized clinical trial that will include 80 patients over 18 years of age with a recent diagnosis of OSA and indication for treatment with CPAP. Participants will be recruited consecutively and will be randomly assigned in a 1: 1 ratio to receive usual information or more detailed information in possible adverse effects of treatment during the CPAP adaptation visit. Follow-up will be performed at 1 month and 3 months after starting CPAP treatment. Side effects and treatment compliance in each of the groups will be blindly assessed. Descriptive statistics and differences in the number of side effects and hours of compliance between the two groups will be performed.
Interventions
OTHERDetailed information
Subjects in this arm will receive usual information + detailed information on side effects
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with OSA with indication for CPAP treatment 2. To be over 18 years old 3. Sign informed consent for study participation.
Exclusion criteria
1. Patients previously treated with CPAP. 2. Patients with other previous treatments for OSA (surgery, mandibular advancement device, etc.) 3. Presence of any other previously diagnosed sleep disorder 4. Patients with\> 50% central sleep apnea or Cheyne-Stokes respiration 5. Diagnosis of a mental or physical condition that makes difficult to complete questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of side effects | at 1 month | Evaluate the number of side effects reported in both arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hours of CPAP use | at 3 month | Number of hours will be collected from the internal clock of the CPAP device |
Countries
Spain
Outcome results
None listed