NCT05284045

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
OTHER	Detailed information	Subjects in this arm will receive usual information + detailed information on side effects

Timeline

• Start date: 2022-03-08
• Primary completion: 2024-03-03
• Completion: 2024-03-03
• First posted: 2022-03-17
• Last updated: 2024-03-05

Locations

1 site across 1 country: Spain