Obstructive Sleep Apnea (OSA)NCT06994247
Boosting CPAP Use in Adults With Severe Sleep Apnea: Role of Motivation and Psychological Factors
A study testing Motivational Telephone Call in people with Obstructive Sleep Apnea (OSA), run by University of Split, School of Medicine at 1 site in Croatia.
Trial summary
The goal of this randomized prospective clinical trial is to examine whether phenotypic traits, psychological characteristics, assessed by STAI (engl. The State-Trait Anxiety Inventory) and IPIP50S (engl. International Personality Item Pool) questionnaires, and patients' self-efficacy, assessed by SEMSA (engl. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Motivational Telephone Call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 14 Apr 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants aged 18 years or older
- Diagnosis of severe obstructive sleep apnea (OSA), defined as AHI ≥30
- Signed informed consent for participation in the study
- Adequate physical and psychological capacity to participate in the intervention and complete questionnaires
- Patients who are initiating CPAP therapy at the Sleep Medicine Center, University of Split School of Medicine
- Availability for follow-up over a three-month period
Who cannot join
- Presence of central sleep apnea or other primary sleep disorders
- Cognitive impairment or psychiatric conditions that may hinder the ability to follow instructions or complete questionnaires
- Previous experience with CPAP therapy prior to study enrollment
- Significant comorbidities (e.g. unstable cardiovascular disease, advanced pulmonary disease) that may interfere with study outcomes
- Pregnancy
- Inability to participate in follow-up assessments or be contacted by telephone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University of Split School of Medicine
Split, Dalmatia, 21000
About this study
Official title: Impact of Phenotypic and Psychological Characteristics and a Motivational Telephone Intervention on Continuous Positive Airway Pressure (CPAP) Adherence in Patients With Severe Obstructive Sleep Apnea
The goal of this randomized prospective clinical trial is to examine whether phenotypic traits, psychological characteristics, assessed by STAI (engl. The State-Trait Anxiety Inventory) and IPIP50S (engl. International Personality Item Pool) questionnaires, and patients' self-efficacy, assessed by SEMSA (engl. Self-Eficacy Measure for Sleep Apnea) questionnaire, are associated with CPAP adherence after three months of use. The study also evaluates whether a motivational phone call one month after therapy initiation improves CPAP adherence at the three-month follow-up. The main questions it aims to answer are:
- Are phenotypic and psychological traits associated with adherence to CPAP therapy after 3 months of treatment?
- Can a single motivational telephone intervention, one month after initiating CPAP therapy, significantly improve CPAP adherence at the three-month follow-up compared to no intervention? Researchers will compare patients who receive a phone call to those who do not, to see if this simple intervention leads to better CPAP adherence after three months of use.
Read more
Participants will:
- Undergo polysomnography before starting CPAP therapy,
- Complete three questionnaires (IPIP50S, STAI, SEMSA) before starting CPAP therapy,
- Be randomly assigned to either receive a motivational phone call one month after starting CPAP therapy or to a control group without any phone call,
- Be invited for a follow-up after three months of CPAP use to download and analyze CPAP adherence data from their CPAP devices.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Motivational Telephone Call
- 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 Telephone CallBehavioural
This intervention consists of a single, personalized motivational telephone call delivered by a medical doctor, one month after initiation of CPAP treatment, uniquely timed to address early barriers and enhance self-efficacy. Unlike standard care or automated follow-ups, it offers tailored support based on patient experience, making it a low-cost yet targeted behavioral strategy to improve adherence. Content of the telephone call includes inquiry about patient's experience with CPAP therapy, identification of barriers to regular use, education on the health benefits of consistent CPAP usage, and personalized motivational messages aimed at increasing compliance.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Telephone Call - Intervention Group | Experimental | Participants in this group will receive standard CPAP therapy along with a motivational telephone intervention. Approximately one month after initiating CPAP therapy, a physician will contact participants by phone to assess usage and discuss any difficulties. During the call, the physician will provide personalized motivation and education regarding the health benefits of consistent CPAP use to enhance treatment adherence.
Timing: At 1 month post-enrollment Delivered by: Medical doctor Mode: Telephone Goal: To improve CPAP adherence at the 3-month follow-up Receives: Behavioral: Motivational Telephone Call |
| No Intervention - Control Group | No intervention | Participants in this group will receive standard CPAP therapy only, without any additional motivational contact beyond routine clinical follow-up. Data on adherence will be collected at the 3-month time point using CPAP device memory cards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Adherence After Three Months of Therapy
CPAP adherence at three months, measured as the percentage of days with CPAP usage ≥4 hours per night, obtained from CPAP device memory cards.
Measured: From baseline (enrollment) to 3-month follow-up
Secondary outcomes (4)
Baseline self-efficacy related to OSA treatment
Self-efficacy related to obstructive sleep apnea (OSA) treatment will be assessed at baseline using the Self-Efficacy Measure for Sleep Apnea (SEMSA) questionnaire. The SEMSA is a validated self-report instrument with scores ranging from 1 to 4, where higher scores indicate greater self-efficacy (i.e., more confidence in using CPAP). The total score is continuous and will be analyzed as a predictor of CPAP adherence at 3 months.
Measured: Baseline
Baseline anxiety levels (state and trait)
Anxiety levels will be assessed at baseline using the State-Trait Anxiety Inventory (STAI), a validated self-report instrument consisting of two subscales: state anxiety and trait anxiety. Each subscale yields a score from 20 to 80, with higher scores indicating greater anxiety. Both scores will be analyzed separately as continuous predictors of CPAP adherence at 3 months.
Measured: Baseline
Baseline personality traits
Personality traits will be measured at baseline using the International Personality Item Pool - 50-item Short Form (IPIP-50). The IPIP-50 evaluates five personality traits: Openness, Conscientiousness, Extraversion, Agreeableness, and Neuroticism. Each trait score is derived from responses on a 1 to 5 Likert scale, with higher scores indicating a stronger presence of that trait. Each trait will be analyzed separately as a categorical or continuous predictor of CPAP adherence at 3 months.
Measured: Baseline
Effect of motivational telephone intervention
Binary exposure variable (intervention: yes/no). CPAP adherence at 3 months will be compared between the intervention and control groups to assess the effect of the motivational telephone intervention.
Measured: From baseline to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start14 Apr 2025
- Primary completion15 Dec 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994247
- Sponsor's protocol ID
- 2181-198-03-04-24-0107
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Phenotypic and Psychological Characteristics and a Motivational Telephone Intervention on Continuous Positive Airway Pressure (CPAP) Adherence in Patients With Severe Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06994247
- Acronym / sponsor ID
- 2181-198-03-04-24-0107
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 29 May 2025 (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.
The goal of this randomized prospective clinical trial is to examine whether phenotypic traits, psychological characteristics, assessed by STAI (engl. The State-Trait Anxiety Inventory) and IPIP50S (engl. International Personality Item Pool) questionnaires, and patients' self-efficacy, assessed by SEMSA (engl. Self-Eficacy Measure for Sleep Apnea) questionnaire, are associated with CPAP adherence after three months of use. The study also evaluates whether a motivational phone call one month after therapy initiation improves CPAP adherence at the three-month follow-up. The main questions it aims to answer are:
- Are phenotypic and psychological traits associated with adherence to CPAP therapy after 3 months of treatment?
- Can a single motivational telephone intervention, one month after initiating CPAP therapy, significantly improve CPAP adherence at the three-month follow-up compared to no intervention? Researchers will compare patients who receive a phone call to those who do not, to see if this simple intervention leads to better CPAP adherence after three months of use.
Participants will:
- Undergo polysomnography before starting CPAP therapy,
- Complete three questionnaires (IPIP50S, STAI, SEMSA) before starting CPAP therapy,
- Be randomly assigned to either receive a motivational phone call one month after starting CPAP therapy or to a control group without any phone call,
- Be invited for a follow-up after three months of CPAP use to download and analyze CPAP adherence data from their CPAP devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Telephone Call - Intervention Group | Experimental | Behavioral: Motivational Telephone CallParticipants in this group will receive standard CPAP therapy along with a motivational telephone intervention. Approximately one month after initiating CPAP therapy, a physician will contact participants by phone to assess usage and discuss any difficulties. During the call, the physician will provide personalized motivation and education regarding the health benefits of consistent CPAP use to enhance treatment adherence. Timing: At 1 month post-enrollment Delivered by: Medical doctor Mode: Telephone Goal: To improve CPAP adherence at the 3-month follow-up |
| No Intervention - Control Group | No intervention | –Participants in this group will receive standard CPAP therapy only, without any additional motivational contact beyond routine clinical follow-up. Data on adherence will be collected at the 3-month time point using CPAP device memory cards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged 18 years or older
- Diagnosis of severe obstructive sleep apnea (OSA), defined as AHI ≥30
- Signed informed consent for participation in the study
- Adequate physical and psychological capacity to participate in the intervention and complete questionnaires
- Patients who are initiating CPAP therapy at the Sleep Medicine Center, University of Split School of Medicine
Key exclusion criteria (6 listed)
- Presence of central sleep apnea or other primary sleep disorders
- Cognitive impairment or psychiatric conditions that may hinder the ability to follow instructions or complete questionnaires
- Previous experience with CPAP therapy prior to study enrollment
- Significant comorbidities (e.g. unstable cardiovascular disease, advanced pulmonary disease) that may interfere with study outcomes
- Pregnancy
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 Telephone CallThis intervention consists of a single, personalized motivational telephone call delivered by a medical doctor, one month after initiation of CPAP treatment, uniquely timed to address early barriers and enhance self-efficacy. Unlike standard care or automated follow-ups, it offers tailored support based on patient experience, making it a low-cost yet targeted behavioral strategy to improve adherence. Content of the telephone call includes inquiry about patient's experience with CPAP therapy, identification of barriers to regular use, education on the health benefits of consistent CPAP usage, and personalized motivational messages aimed at increasing compliance. | Behavioural | Motivational Telephone Call - Intervention Group |
Primary outcome
CPAP Adherence After Three Months of Therapy
Time frame: From baseline (enrollment) to 3-month follow-up
CPAP adherence at three months, measured as the percentage of days with CPAP usage ≥4 hours per night, obtained from CPAP device memory cards.
4 secondary outcomes
Baseline self-efficacy related to OSA treatment
Time frame: Baseline
Baseline anxiety levels (state and trait)
Time frame: Baseline
Baseline personality traits
Time frame: Baseline
Effect of motivational telephone intervention
Time frame: From baseline to 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
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 Telephone Call in people with Obstructive Sleep Apnea (OSA), run by University of Split, School of Medicine at 1 site in Croatia.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 May 2025. 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 Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivana Pavlinac Dodig, Assoc. Prof. (+38521557853, ivana.pavlinac@mefst.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP Adherence After Three Months of Therapy (time frame: From baseline (enrollment) to 3-month follow-up). 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 29 May 2025.