Nocebo Effect in OSA Patients With CPAP Treatment

Obstructive Sleep Apnea Clinical Trial

Official title:

Study of the Nocebo Effect in Patients With Obstructive Sleep Apnea Syndrome and Treatment With Continuous Positive Airway Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05284045
• Other study ID #: HCB/2021/1330
• Status: Completed
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: March 3, 2024

Study information

• Verified date: March 2024
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 3, 2024
• Est. primary completion date: March 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Detailed information
Subjects in this arm will receive usual information + detailed information on side effects

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of side effects	Evaluate the number of side effects reported in both arms	at 1 month
Secondary	Hours of CPAP use	Number of hours will be collected from the internal clock of the CPAP device	at 3 month