Nocebo Effect in OSA Patients With CPAP Treatment
Study of the Nocebo Effect in Patients With Obstructive Sleep Apnea Syndrome and Treatment With Continuous Positive Airway Pressure
1 other identifier
interventional
97
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2022
CompletedStudy Start
First participant enrolled
March 8, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2024
CompletedMarch 5, 2024
March 1, 2024
2 years
February 28, 2022
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of side effects
Evaluate the number of side effects reported in both arms
at 1 month
Secondary Outcomes (1)
Hours of CPAP use
at 3 month
Study Arms (2)
Usual information
NO INTERVENTIONSubjects allocated to this arm will receive the usual information about OSA and CPAP treatment given in clinical practise
Detailed information
ACTIVE COMPARATORSubjects 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.
Interventions
Subjects in this arm will receive usual information + detailed information on side effects
Eligibility Criteria
You may qualify if:
- Patients diagnosed with OSA with indication for CPAP treatment
- To be over 18 years old
- Sign informed consent for study participation.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clinic Barcelona
Barcelona, 08036, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mireia DALMASES CLERIES
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 17, 2022
Study Start
March 8, 2022
Primary Completion
March 3, 2024
Study Completion
March 3, 2024
Last Updated
March 5, 2024
Record last verified: 2024-03