Obstructive Sleep ApneaNCT05284045
Nocebo Effect in OSA Patients With CPAP Treatment
A study testing Detailed information in people with Obstructive Sleep Apnea, run by Hospital Clinic of Barcelona at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Detailed information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSpain
- Study dates
- 8 Mar 2022to 3 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with OSA with indication for CPAP treatment
- To be over 18 years old
- Sign informed consent for study participation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Detailed information
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed informationOther
Subjects in this arm will receive usual information + detailed information on side effects
| Study group | Role | What they receive |
|---|---|---|
| Usual information | No intervention | Subjects allocated to this arm will receive the usual information about OSA and CPAP treatment given in clinical practise |
| Detailed information | Active comparator | 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. Receives: Other: Detailed information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of side effects
Evaluate the number of side effects reported in both arms
Measured: at 1 month
Secondary outcomes (1)
Hours of CPAP use
Number of hours will be collected from the internal clock of the CPAP device
Measured: at 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start8 Mar 2022
- Primary completion3 Mar 2024
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireia Dalmases, Hospital Clinic of Barcelona
- Investigators
- Mireia DALMASES CLERIES, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284045
- Sponsor's protocol ID
- HCB/2021/1330
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Nocebo Effect in Patients With Obstructive Sleep Apnea Syndrome and Treatment With Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT05284045
- Acronym / sponsor ID
- HCB/2021/1330
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual information | No intervention | –Subjects allocated to this arm will receive the usual information about OSA and CPAP treatment given in clinical practise |
| Detailed information | Active comparator | Other: Detailed informationSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with OSA with indication for CPAP treatment
- To be over 18 years old
- Sign informed consent for study participation.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detailed informationSubjects in this arm will receive usual information + detailed information on side effects | Other | Detailed information |
Primary outcome
Number of side effects
Time frame: at 1 month
Evaluate the number of side effects reported in both arms
1 secondary outcome
Hours of CPAP use
Time frame: at 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireia DALMASES CLERIES principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detailed information in people with Obstructive Sleep Apnea, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of side effects (time frame: at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.