Using an Educational Video to Enhance Adherence of CPAP Therapy in Thai OSA Patients: a Randomised Controlled Trial

NCT06684717 | Completed

• 1 other identifier: 042/2566(IRB2)
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find out whether video education helps improve CPAP adherence in OSA patients or not The main questions it aims to answer are: Does educational video intervention help improve CPAP adherence in Thai OSA patients? What factors predict good CPAP adherence in OSA patients? Participants will: be randomized into video intervention group and usual care group with simple random sampling method. Demographics, Epworth Sleepiness scale scores (ESS), Pittsburg sleep quality scores, polysomnographic data and CPAP usage data were recorded.

Conditions

OSA

Outcome Measures

Primary Outcomes (1)

• CPAP adherence rate at 3 weeks after intervention.

  The percent of participants meeting the criteria for good CPAP adherence (more than 4 hours per night and more than 70% of all days used) at 3 weeks in the video intervention group compared to the usual care group. Usage data for the past 3 weeks.

  3 weeks

Study Arms (2)

Educational video intervention group

EXPERIMENTAL

The participants who were randomized into the video group watched a 3-minute video that educated patients about OSA, treatment, and its benefits. We also added the scenario of the real patients who were currently using CPAP, in order to motivated participants to use CPAP more. The participants in the video group also received routine care.

Behavioral: Educational video intervention

Usual care group

NO INTERVENTION

In the usual care group, they were routinely advised about the disease and CPAP machine use by sleep medicine doctors and sleep technicians.

Interventions

Educational video intervention BEHAVIORAL

A 3-minute educational video mainly about the benefits of Continuous positive airway pressure therapy in OSA patients. The video starts with basic knowledge about OSA and how it affects human health. What is a CPAP machine and how does it works? It was developed from consensus among expert opinions of Neurobehavioral specialists and sleep physicians.

Educational video intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who were diagnosed with moderate to severe OSA or mild OSA with indication for CPAP therapy by standard polysomnography (PSG) from 1 December 2022 and 31 May 2023 at Siriraj Sleep Center. Diagnosis of obstructive sleep apnea (OSA) was done according to the AASM criteria; mild (AHI 5 to ≤ 15 events/h), moderate (AHI 15 to ≤ 30 events/h) and severe (AHI ≥ 30 events/h).

You may not qualify if:

• Participants who were not CPAP naïve, had central sleep apnea, had comorbidities that were contraindicated for CPAP therapy or denied using CPAP.

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Random permuted blocks design was used to randomly assign each participant into video education intervention and usual care group by a research assistant, without the principal investigator knowing.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Model Details: Inclusion criteria were adults (older than age 18) who were diagnosed with moderate to severe OSA or mild OSA with an indication for CPAP therapy by standard polysomnography (PSG) from 1 December 2022 and 31 May 2023 at Siriraj sleep center. Diagnosis of obstructive sleep apnea (OSA) was done according to the AASM criteria; mild (AHI 5 to ≤ 15 events/h), moderate (AHI 15 to ≤ 30 events/h) and severe (AHI ≥ 30 events/h). Subjects who were not CPAP naïve had central sleep apnea, had comorbidities that were contraindicated for CPAP therapy, or denied using CPAP were excluded.

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 12, 2024
• Study Start: February 24, 2023
• Primary Completion: February 17, 2024
• Study Completion: February 23, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)