Nocebo Effect in OSA Patients With CPAP Treatment
Primary Purpose
Obstructive Sleep Apnea
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Detailed information
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with OSA with indication for CPAP treatment
- To be over 18 years old
- Sign informed consent for study participation.
Exclusion Criteria:
- Patients previously treated with CPAP.
- Patients with other previous treatments for OSA (surgery, mandibular advancement device, etc.)
- Presence of any other previously diagnosed sleep disorder
- Patients with> 50% central sleep apnea or Cheyne-Stokes respiration
- Diagnosis of a mental or physical condition that makes difficult to complete questionnaires
Sites / Locations
- Hospital Clinic Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual information
Detailed information
Arm Description
Subjects allocated to this arm will receive the usual information about OSA and CPAP treatment given in clinical practise
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.
Outcomes
Primary Outcome Measures
Number of side effects
Evaluate the number of side effects reported in both arms
Secondary Outcome Measures
Hours of CPAP use
Number of hours will be collected from the internal clock of the CPAP device
Full Information
NCT ID
NCT05284045
First Posted
February 28, 2022
Last Updated
September 22, 2023
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT05284045
Brief Title
Nocebo Effect in OSA Patients With CPAP Treatment
Official Title
Study of the Nocebo Effect in Patients With Obstructive Sleep Apnea Syndrome and Treatment With Continuous Positive Airway Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual information
Arm Type
No Intervention
Arm Description
Subjects allocated to this arm will receive the usual information about OSA and CPAP treatment given in clinical practise
Arm Title
Detailed information
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Detailed information
Intervention Description
Subjects in this arm will receive usual information + detailed information on side effects
Primary Outcome Measure Information:
Title
Number of side effects
Description
Evaluate the number of side effects reported in both arms
Time Frame
at 1 month
Secondary Outcome Measure Information:
Title
Hours of CPAP use
Description
Number of hours will be collected from the internal clock of the CPAP device
Time Frame
at 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with OSA with indication for CPAP treatment
To be over 18 years old
Sign informed consent for study participation.
Exclusion Criteria:
Patients previously treated with CPAP.
Patients with other previous treatments for OSA (surgery, mandibular advancement device, etc.)
Presence of any other previously diagnosed sleep disorder
Patients with> 50% central sleep apnea or Cheyne-Stokes respiration
Diagnosis of a mental or physical condition that makes difficult to complete questionnaires
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireia DALMASES CLERIES
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Nocebo Effect in OSA Patients With CPAP Treatment
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