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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Detailed information

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual information; Subjects allocated to this arm will receive the usual information about OSA and CPAP treatment given in clinical practise
Active Comparator: 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.	Other: Detailed information; Subjects in this arm will receive usual information + detailed information on side effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of side effects	Evaluate the number of side effects reported in both arms	at 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hours of CPAP use	Number of hours will be collected from the internal clock of the CPAP device	at 3 month

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Mireia DALMASES CLERIES, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Actual): March 3, 2024
• Study Completion (Actual): March 3, 2024

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: HCB/2021/1330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No