Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2022-03-08
2024-03-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Usual information
Subjects allocated to this arm will receive the usual information about OSA and CPAP treatment given in clinical practise
No interventions assigned to this group
Detailed information
Subjects allocated to this arm will also receive the usual information about OSA and CPAP treatment and they will also receive information related to the possible adverse side effects of CPAP treatment. The healthcare professional will enumerate the possible side effects and indicate which are more and less common.
Detailed information
Subjects in this arm will receive usual information + detailed information on side effects
Interventions
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Detailed information
Subjects in this arm will receive usual information + detailed information on side effects
Eligibility Criteria
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Inclusion Criteria
2. To be over 18 years old
3. Sign informed consent for study participation.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Hospital Clinic of Barcelona
OTHER
Responsible Party
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Mireia Dalmases
Principal Investigator
Principal Investigators
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Mireia DALMASES CLERIES
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clinic Barcelona
Barcelona, , Spain
Countries
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Other Identifiers
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HCB/2021/1330
Identifier Type: -
Identifier Source: org_study_id
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