Sleep Apnea, ObstructiveMotivAirNCT05767190
The MotivAir Study to Improve CPAP Adherence in OSAS Patients
A study testing Motivational interviewing in people with Sleep Apnea, Obstructive and Motivational Interviewing, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
This study aims to evaluate the effectiveness of the MotivAir program an intervention based on Motivational Interviewing (MI) principles and techniques - in enhancing adherence to Continuous Positive Airway Pressure (CPAP) therapy among patients with Obstructive Sleep Apnea Syndrome (OSAS). Methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Apnea, Obstructive, Motivational Interviewing
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2023to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- having a diagnosis of OSAS confirmed by polysomnography;
- being recommended for treatment with CPAP;
- being naïve to this type of intervention
Who cannot join
- use of oxygen therapy > 2 l/min;
- history of severe cognitive disorders;
- history of COPD: FEV1/FVC (Tiffeneau Index) ≤ 60% with FEV1 ≤ 50%;
- dyspnea on exertion (Borg > 6);
- diagnosis of Long Covid or Covid-19 infection < 4 months;
- chronic heart failure (NYHA: Grade III and IV);
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- unstable ischemic heart disease;
- inability to understand the consent to participate;
- patient refusal.
Trial locations and contacts
1 site in 1 country.
Italy1 site
San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS
Verbania, 28921
About this study
Official title: The MotivAir Study: a Randomized Controlled Trial of Motivational Interviewing-Based Intervention to Improve Adherence to CPAP in Patients With Obstructive Sleep Apnea Syndrome
This study aims to evaluate the effectiveness of the MotivAir program an intervention based on Motivational Interviewing (MI) principles and techniques - in enhancing adherence to Continuous Positive Airway Pressure (CPAP) therapy among patients with Obstructive Sleep Apnea Syndrome (OSAS).
Methods. A multicenter randomized controlled trial (RCT) design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program (usual care plus MI) with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients.
A minimum sample of 80 participants (40 patients per group) will be recruited in each center according to the inclusion criteria. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 180 days and will be delivered by a trained nurse. The impact of the MotivAir program on selected primary (adherence to CPAP in terms of average hours of usage per night and the Apnea-Hypopnea Index, AHI) and secondary (motivation, perceived competence, quality of life, sleepiness, as well as the emotional state, daily life activities, and quality of the social relationships of the person) outcomes will be measured at baseline, and after 1-, 3-, and 6-month from CPAP initiation
Read the detailed description
Socio-demographic (age, level of studies, presence of caregiver at home), psychological (motivation and perceived competence) clinical variables (somnolence and apnoea-hypopnea index), and variables concerning the time the patient spends from home to the care center and the confidence in using electronic applications will be used to classify patients' adherence to treatment as low, moderate or high, and to create a tailored motivational treatment plan for the subjects assigned to the experimental group. Patients showing low adherence will receive a more intensive care plan, than those recognized as highly compliant with CPAP use. The results are patients with the "a" profile (characterized by autonomy and mobility, predisposition to remote-controlled follow-up), patients with the "b" profile (need for more intensity in follow-up), or patients with the "c" profile (more difficulties to move around and require more intensive treatment). Profile "d" was applied to patients who were professional drivers, as they require specific interventions based on their occupation (see Rudilla et al., 2021a).
Participants assigned to the control group will receive a usual pulmonary rehabilitation program for patients with OSAS receiving CPAP therapy, which is a standard technical training comprising information regarding the use, maintenance and safety measures of the device, plus a home inspection delivered by a technician who has the only task of doing maintenance to the machinery.
In addition, subjects in the MotivAir group will follow a telephone-based intervention - lasting approximately 45 minutes - based on MI principles and techniques delivered by a nurse. For the specific purpose of the study, the nurse will preliminarily receive 8 hours of MI training provided by two psychologists experts in the MI approach (authors GR and GP). During the training, the nurse will learn about the collaborative, evocative, and client-centered spirit of MI, and the characteristics that define each stage of change and will be instructed to apply the basic communication and listening skills of this approach (open-ended questions, affirmations, reflective listening, summarizing). Then she will learn to reinforce and elicit change talk, while also responding in ways that reduce counter-change talk and to roll with the patients' inner resistance to change by affirming the patients' autonomy and reflecting their resistant speech with empathy. Next, the issues of how and when to introduce the development of a change plan, and enhance the individuals' commitment to change will be addressed.
The treatment plan will be implemented based on each patient's level of adherence. To low adherence (score below 16 on the ESS and CEPCA questionnaires) a more intensive telephone-based assistance (day 1, 8, 16, 30, 90, 120, 180 from the end of the rehabilitation period) will follow. In the case of high adherence (score greater than or equal to 16 on the ESS and CEPCA questionnaires), phone encounters will be set on days 1, 8, 30, 90, and 180 after treatment termination.
At 1-, 3- and 6-month follow-up, adherence to the device will be assessed by automatedly recorded CPAP usage (hours/night) and AHI. Changes in the selected psychological variable will be also examined.
- Being tested
- Motivational interviewing
- 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.
Motivational interviewingBehavioural
During the intervention, the trained-nurse will provide a motivational interviewing-based intervention consisting of one session divided into two parts: educational (the concepts of sleep apnea and the symptoms, and the CPAP treatment will be focused on) and training activity (using MI not directly advocate for behavioral change (i.e., use CPAP as prescribed), but asks key questions to help the patient explore conflicting feelings about the change, weighs the positive consequences and negatives of this change, and allows the patient to realize the discrepancy between current risk behavior (i.e. not using CPAP as directed) and the patient's self-identified goals. The intervention will be tailored on the patient's stage of change based on Prochaska and DiClemente transtheoretical model (1982), in fact, the nurse will use MI not only at the beginning of therapy but also in every contact with the patient throughout the treatment (subsequent follow-up visits, phone calls, etc.).
| Study group | Role | What they receive |
|---|---|---|
| MotivAir group | Experimental | Subjects in the MotivAir group will follow an intervention - lasting approximately 45 minutes - based on motivational interviewing principles and techniques delivered by a trained nurse. Receives: Behavioral: Motivational interviewing |
| Treatment as usual | No intervention | Participants assigned to the control group will receive a usual pulmonary rehabilitation program for patients with OSAS receiving CPAP therapy, which is a standard technical training comprising information regarding the use, maintenance and safety measures of the device, plus a home inspection delivered by a technician who has the only task of doing maintenance to the machinery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline adherence to CPAP at 6 months
average hours of usage per night
Measured: 6 months from CPAP initiation
Change from baseline Apnea-Hypopnea Index (AHI) at 6 months
severity of apnea-hypopnea
Measured: 6 months from CPAP initiation
Secondary outcomes (3)
Change from baseline Motivation to change at 6 months
the need for changes in your lifestyle to make it healthier with a single item
Measured: 6 months from CPAP initiation
Change from baseline of Evaluation of Perceived Competence in Adherence to CPAP in OSAS at 3 and 6 months
self-efficacy in overcoming barriers associated with the use of the cpap
Measured: 6 months from CPAP initiation
Change from Baseline of Visual Analogical Well-being Scale for apnea at 6 months
quality of life
Measured: 6 months from CPAP initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianluca Castelnuovo, PhD, Principal investigator, Istututo Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767190
- Sponsor's protocol ID
- 03J101
- Acronym
- MotivAir
- Status last verified
- Mar 2023
- First submitted
- 12 May 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of the study published in a repository and in an International Journal
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MotivAir Study: a Randomized Controlled Trial of Motivational Interviewing-Based Intervention to Improve Adherence to CPAP in Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT05767190
- Acronym / sponsor ID
- MotivAir / 03J101
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Mar 2023 (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 aims to evaluate the effectiveness of the MotivAir program an intervention based on Motivational Interviewing (MI) principles and techniques - in enhancing adherence to Continuous Positive Airway Pressure (CPAP) therapy among patients with Obstructive Sleep Apnea Syndrome (OSAS).
Methods. A multicenter randomized controlled trial (RCT) design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program (usual care plus MI) with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients.
A minimum sample of 80 participants (40 patients per group) will be recruited in each center according to the inclusion criteria. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 180 days and will be delivered by a trained nurse. The impact of the MotivAir program on selected primary (adherence to CPAP in terms of average hours of usage per night and the Apnea-Hypopnea Index, AHI) and secondary (motivation, perceived competence, quality of life, sleepiness, as well as the emotional state, daily life activities, and quality of the social relationships of the person) outcomes will be measured at baseline, and after 1-, 3-, and 6-month from CPAP initiation
Detailed description
Socio-demographic (age, level of studies, presence of caregiver at home), psychological (motivation and perceived competence) clinical variables (somnolence and apnoea-hypopnea index), and variables concerning the time the patient spends from home to the care center and the confidence in using electronic applications will be used to classify patients' adherence to treatment as low, moderate or high, and to create a tailored motivational treatment plan for the subjects assigned to the experimental group. Patients showing low adherence will receive a more intensive care plan, than those recognized as highly compliant with CPAP use. The results are patients with the "a" profile (characterized by autonomy and mobility, predisposition to remote-controlled follow-up), patients with the "b" profile (need for more intensity in follow-up), or patients with the "c" profile (more difficulties to move around and require more intensive treatment). Profile "d" was applied to patients who were professional drivers, as they require specific interventions based on their occupation (see Rudilla et al., 2021a).
Participants assigned to the control group will receive a usual pulmonary rehabilitation program for patients with OSAS receiving CPAP therapy, which is a standard technical training comprising information regarding the use, maintenance and safety measures of the device, plus a home inspection delivered by a technician who has the only task of doing maintenance to the machinery.
In addition, subjects in the MotivAir group will follow a telephone-based intervention - lasting approximately 45 minutes - based on MI principles and techniques delivered by a nurse. For the specific purpose of the study, the nurse will preliminarily receive 8 hours of MI training provided by two psychologists experts in the MI approach (authors GR and GP). During the training, the nurse will learn about the collaborative, evocative, and client-centered spirit of MI, and the characteristics that define each stage of change and will be instructed to apply the basic communication and listening skills of this approach (open-ended questions, affirmations, reflective listening, summarizing). Then she will learn to reinforce and elicit change talk, while also responding in ways that reduce counter-change talk and to roll with the patients' inner resistance to change by affirming the patients' autonomy and reflecting their resistant speech with empathy. Next, the issues of how and when to introduce the development of a change plan, and enhance the individuals' commitment to change will be addressed.
The treatment plan will be implemented based on each patient's level of adherence. To low adherence (score below 16 on the ESS and CEPCA questionnaires) a more intensive telephone-based assistance (day 1, 8, 16, 30, 90, 120, 180 from the end of the rehabilitation period) will follow. In the case of high adherence (score greater than or equal to 16 on the ESS and CEPCA questionnaires), phone encounters will be set on days 1, 8, 30, 90, and 180 after treatment termination.
At 1-, 3- and 6-month follow-up, adherence to the device will be assessed by automatedly recorded CPAP usage (hours/night) and AHI. Changes in the selected psychological variable will be also examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MotivAir group | Experimental | Behavioral: Motivational interviewingSubjects in the MotivAir group will follow an intervention - lasting approximately 45 minutes - based on motivational interviewing principles and techniques delivered by a trained nurse. |
| Treatment as usual | No intervention | –Participants assigned to the control group will receive a usual pulmonary rehabilitation program for patients with OSAS receiving CPAP therapy, which is a standard technical training comprising information regarding the use, maintenance and safety measures of the device, plus a home inspection delivered by a technician who has the only task of doing maintenance to the machinery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- having a diagnosis of OSAS confirmed by polysomnography;
- being recommended for treatment with CPAP;
- being naïve to this type of intervention
Key exclusion criteria (9 listed)
- use of oxygen therapy > 2 l/min;
- history of severe cognitive disorders;
- history of COPD: FEV1/FVC (Tiffeneau Index) ≤ 60% with FEV1 ≤ 50%;
- dyspnea on exertion (Borg > 6);
- diagnosis of Long Covid or Covid-19 infection < 4 months;
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 |
|---|---|---|
| Motivational interviewingDuring the intervention, the trained-nurse will provide a motivational interviewing-based intervention consisting of one session divided into two parts: educational (the concepts of sleep apnea and the symptoms, and the CPAP treatment will be focused on) and training activity (using MI not directly advocate for behavioral change (i.e., use CPAP as prescribed), but asks key questions to help the patient explore conflicting feelings about the change, weighs the positive consequences and negatives of this change, and allows the patient to realize the discrepancy between current risk behavior (i.e. not using CPAP as directed) and the patient's self-identified goals. The intervention will be tailored on the patient's stage of change based on Prochaska and DiClemente transtheoretical model (1982), in fact, the nurse will use MI not only at the beginning of therapy but also in every contact with the patient throughout the treatment (subsequent follow-up visits, phone calls, etc.). | Behavioural | MotivAir group |
Primary outcome
Change from Baseline adherence to CPAP at 6 months
Time frame: 6 months from CPAP initiation
average hours of usage per night
Change from baseline Apnea-Hypopnea Index (AHI) at 6 months
Time frame: 6 months from CPAP initiation
severity of apnea-hypopnea
3 secondary outcomes
Change from baseline Motivation to change at 6 months
Time frame: 6 months from CPAP initiation
Change from baseline of Evaluation of Perceived Competence in Adherence to CPAP in OSAS at 3 and 6 months
Time frame: 6 months from CPAP initiation
Change from Baseline of Visual Analogical Well-being Scale for apnea at 6 months
Time frame: 6 months from CPAP initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No. Results of the study published in a repository and in an International Journal
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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.
Gianluca Castelnuovo, PhD principal investigator
Istututo Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Sleep Apnea, Obstructive and Motivational Interviewing, run by Istituto Auxologico Italiano at 1 site in Italy.
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 9 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianluca Castelnuovo, PhD (0039323514338, gianluca.castelnuovo@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline adherence to CPAP at 6 months (time frame: 6 months from CPAP initiation). The study lists 2 primary outcomes in all. 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 22 Mar 2023.