Nocebo Effect in OSA Patients With CPAP Treatment

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Detailed information

• Registration Number: NCT05284045
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study Start: 2022-03-08
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Status Verified: 2024-03
• Primary Completion: 2024-03-03
• Study Completion: 2024-03-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Detailed information	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.

Primary Outcome Measures

Name	Time	Method
Number of side effects	at 1 month	Evaluate the number of side effects reported in both arms

Secondary Outcome Measures

Name	Time	Method
Hours of CPAP use	at 3 month	Number of hours will be collected from the internal clock of the CPAP device

Trial Locations

Locations (1)

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain