Educational Motivational Program on Sleep Apnea

NCT06668597 | Recruiting DMC

• 1 other identifier: ME-CA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to introduce a motivational intervention for patients with Obstructive Sleep Apnea (OSA) starting CPAP therapy to improve sleep quality and treatment adherence. It will assess average daily CPAP use and compare subjective sleep quality, daytime sleepiness, disease perception, and quality of life between the intervention group and a control group receiving standard care. Inclusion criteria are adults with OSA capable of understanding Italian; exclusion criteria are minors and those already adapted to CPAP. The experimental group will receive a four-phase motivational intervention, while the control group will follow standard CPAP adaptation without additional support.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Obstructive Sleep Apnea; Continuous Positive Airway Pressure; Motivational Intervention; Sleep Management; Telemedicine; Psychoeducation

Outcome Measures

Primary Outcomes (3)

• Brief Illness Perception Questionnaire

  A self-report questionnaire consisting of 9 items, rated on a 10-point Likert scale, used to assess illness perception, ranging from mild to high. All of the items except the causal question are rated using a 0-to-10 response scale. The total score is calculated by summing the scores of all eight items where items 3, 4, and 7 are inversed. The possible range of scores is 0-80. The higher the score, the greater the perceived threat of the illness.

  At enrollment, one week after the end of the intervention and three months later.

• Pittsburgh Sleep Quality Index (PSQI)

  A self-report questionnaire consisting of 10 items, using a 4-point Likert scale (0-3), used for the subjective assessment of sleep quality over the past month, specifically evaluating dimensions related to sleep efficiency and latency, duration, medication use, the presence of factors disturbing sleep (e.g., pain, heat, etc.), and the impact on quality of life. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

  At enrollment, one week after the end of the intervention and three months later.

• Epworth Sleepiness Scale (ESS)

  A self-report questionnaire consisting of 8 items on a 4-point Likert scale (0-3), used to assess daytime sleepiness in various daily life contexts, such as being a passenger in a car, reading, or attending a theater performance. The Epworth sleepiness scale results range from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness. A result under 10 may not be cause for concern or it could identify you have trouble sleeping (insomnia). A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness.

  At enrollment, one week after the end of the intervention and three months later.

Secondary Outcomes (3)

• Short Form Health Survey - 12

  At enrollment, one week after the end of the intervention and three months later.

• Self-Efficacy Measure for Sleep Apnea (SEMSA)

  At enrollment and one week after the end of the intervention

• System Usability Scale (SUS)

  At enrollment, one week after the end of the intervention and three months later.

Study Arms (2)

Psychoeducation Program

EXPERIMENTAL

The experimental group will receive a motivational psychoeducational intervention consisting of four phases: Phase 1 (Pre-adaptation Psychoeducation): The intervention begins with the pulmonologist's decision for home adaptation to CPAP for the patient diagnosed with OSA. The participant will receive necessary materials and an educational video (25 minutes) within two days before the provider's home visit. Phase 2 (Motivational Interview): After the first night of CPAP use, the participant will have a brief motivational interview via phone. Phase 3 (Psychological Support Interview): One week after the provider's intervention, the participant will have a support interview regarding the adaptation process (40 minutes). This first week is a high-risk period for device abandonment. Phase 4 (Monitoring Interview): Two weeks after the provider's intervention, the participant will have a monitoring interview (30 minutes) to check for any difficulties during the adaptation process.

Behavioral: Motivational educational program to improve sleep quality in OSA patients through adherence to CPAP

Treatment as usual

NO INTERVENTION

The patient, following the visit with the pulmonologist specializing in sleep medicine, who has been diagnosed with OSA, will be invited to proceed with the home adaptation process for the CPAP device by the staff.

Interventions

Motivational educational program to improve sleep quality in OSA patients through adherence to CPAP BEHAVIORAL

Phase 1 (Pre-adaptation Psychoeducation): The participant will be shown, within two days prior to the home visit by the provider, which usually takes place within three days of the visit with the pulmonologist, the necessary materials (device, masks, and tubing), along with an educational video on the topic of OSA (duration 25 minutes); Phase 2 (Motivational Interview): Following the first night of titration and use of the CPAP, the participant will be contacted by phone for a brief motivational interview (duration 25 minutes); Phase 3 (Psychological Support Interview): One week after the provider's intervention and the start of the CPAP adaptation period, the participant will be contacted again for a support interview regarding the adaptation process to CPAP (duration 40 minutes). The first week of adaptation is considered a high-risk period for abandonment of device use; Phase 4 (Monitoring Interview): Two weeks after the provider's intervention and the start o

Psychoeducation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients with OSA (divided, according to the Task Force of the American Academy of Sleep Medicine (Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The report of an American Academy of Sleep Medicine Task Force. Sleep. 1999;22(5):667-689) into: Mild OSA with AHI between 5 and 15 Moderate OSA with AHI between 15 and 30 Severe OSA with AHI \> 30
• OSA patients who need to begin their home adaptation process to CPAP
• OSA patients who are able to understand the Italian language

You may not qualify if:

• Minor patients
• Patients already adapted to CPAP
• Patients unable to understand the Italian language

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (2)

Don Gnocchi Foundation

Milan, Milan, 20148, Italy

RECRUITING

IRCCS Fondazione Don Gnocchi

Milan, MI, 20148, Italy

RECRUITING

Related Publications (4)

• Sampaio R, Pereira MG, Winck JC. Psychological morbidity, illness representations, and quality of life in female and male patients with obstructive sleep apnea syndrome. Psychol Health Med. 2012;17(2):136-49. doi: 10.1080/13548506.2011.579986. Epub 2011 Jul 11.

  PMID: 21745022 BACKGROUND

• Poletti V, Battaglia EG, Banfi P, Volpato E. Effectiveness of continuous positive airway pressure therapy on romantic relationships and intimacy among individuals with obstructive sleep apnea: A systematic review and a meta-analysis. J Sleep Res. 2025 Feb;34(1):e14262. doi: 10.1111/jsr.14262. Epub 2024 Jun 24.

  PMID: 38925562 BACKGROUND

• Shapiro GK, Shapiro CM. Factors that influence CPAP adherence: an overview. Sleep Breath. 2010 Dec;14(4):323-35. doi: 10.1007/s11325-010-0391-y. Epub 2010 Jul 27.

  PMID: 20661654 BACKGROUND

• Lai AYK, Fong DYT, Lam JCM, Weaver TE, Ip MSM. The efficacy of a brief motivational enhancement education program on CPAP adherence in OSA: a randomized controlled trial. Chest. 2014 Sep;146(3):600-610. doi: 10.1378/chest.13-2228.

  PMID: 24810282 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Eleonora Volpato, PhD

  IRCCS Fondazione Don Gnocchi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleonora Volpato, PhD

CONTACT

3293782692; eleonora.volpato@unicatt.it

Valentina Poletti, MS

CONTACT

3485446235; valentina.poletti@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: January 8, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)