AzTrials
AzTrials

OSANCT06684717

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

A study testing Educational video intervention in people with OSA, run by Siriraj Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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?… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
OSA
What is being tested?
Educational video intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteThailand
Study dates
24 Feb 2023to 23 Feb 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 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Siriraj Hospital, Mahidol University

    Bangkok, 10700

Other trials in Thailand

About this study

Official title: Using an Educational Video to Enhance Adherence of Continuous Positive Pressure Therapy in Thai Obstructive Sleep Apnea Patients: a Randomised Controlled Trial

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.

Read the detailed description

INTRODUCTION

The prevalence of obstructive sleep apnea (OSA) is increasing globally. Continuous positive airway pressure (CPAP) therapy is the most frequently used and effective treatment for moderate and severe OSA. It has been proven to improve sleep quality and decrease cardiovascular events, such as stroke and myocardial infarction.

When treating OSA with CPAP, one essential obstacle is the challenge of obtaining adequate compliance. Good compliance is defined as use during at least 4 h/night and for more than 70% of nights. It appeared that the longer nightly uses is associated with better functional outcomes such as daytime sleepiness. Best results for quality of life improvements and optimal reductions in blood pressure also occur when CPAP usage ≥ 4 h/night. However, the previous data demonstrated subjective adherence ranges of 65%-90%, whereas objective measures of CPAP adherence demonstrated use in the range of 40%-83%. There were various interventions to improve CPAP adherence including education, behavioral, technological, and supportive strategies. Among all, education strategy remains the most consistent intervention in CPAP naïve patients, since the common causes of poor CPAP adherence are patients' negative perceptions of the benefit and health value of CPAP and also lack of confidence in the therapeutic effect of CPAP results. From the previous study, systemic education tends to improve adherence approximately 35 to 50 minutes per night. According to the American Academy of Sleep Medicine Clinical Practice Guideline for Treatment of Adult OSA with Positive Airway Pressure (PAP), strongly recommend that educational interventions be given prior to initiation of PAP therapy in adults with OSA. Wiese et al. found that OSA patients with educational video intervention had a higher rate of return at the clinic. However, objective CPAP adherence was not available most of patients. It is shown that the adherence rate to CPAP therapy tends to be improved by visual education although not significant in a study by Basoglu et al.

In recent study which assessed the impact of a video on CPAP adherence in a population of patients at increased risk for poor CPAP adherence, the results were not significant. Despite the insignificant results of the previous studies, we still decided to evaluate the impact of educational videos on CPAP usage in Thai patients which is low cost and requires lower manpower. To the best of our knowledge, this is the first study about the effectiveness of video education in CPAP adherence improvement in the Thai population.

The primary aim of this study was to find out whether video education would benefit CPAP adherence rate in OSA patients or not.

MATERIALS AND METHODS Participants This was a randomized controlled trial study. Inclusion criteria were adults (older than age 18) 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). Subjects who were not CPAP naïve, had central sleep apnea, had comorbidities which were contraindicated for CPAP therapy or denied using CPAP were excluded. Sample size calculation was done based on previous studies and expert opinion from our research team discussion. An estimated total sample size was 132. Procedure

  1. Enrolled patients were informed about the study and asked for consent form on the date of appointment after PSG study. 5
  2. The demographic data and PSG study result were recorded. The Epworth Sleepiness Scale (ESS), Fatigue Severity Scale(FSS) and Pittsburg Sleep Quality Index(PSQI) were also obtained.
  3. Random permuted blocks design was used to randomly assigned each participant into video education intervention and usual care group.
  4. The participants who were randomized into the video group watched a 3 minute video which 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 usual care.
  5. In the usual care group, they were routinely advised about the disease and CPAP machine use by sleep medicine doctors and sleep technicians.
  6. After prescribed with CPAP therapy, all patients were appointed to return at 3 weeks.
  7. CPAP usage data and sleep questionnaire were collected at 3 weeks. Outcome Analysis The primary outcome was percent meeting previous criteria for good adherence (2) at 3 weeks in video intervention group compared to usual care group. Usage data for the past 3 weeks was retrieved from the device memory card. While the secondary outcome were average CPAP usage all days (hours per night) at 3 weeks in video intervention group compared to usual care group, the % of days with an CPAP usage of ≥4 h at 3 weeks in video intervention group compared to usual care. The study was approved by the Human research ethics committee of Siriraj hospital, Mahidol university (SIRB protocol No. 042/2566).

STATISTICAL ANALYIS Descriptive statistical analysis was performed using the SPSS 20.0. Continuous variables were expressed as mean and standard deviation while categorical variables were expressed as number and percentage. Comparisons between groups were carried out with Mann-Whitney U test or Student's t-test. Categorical variables were compared with the chi-square test. Statistical significance was considered as p-value less than 0.05.

Conditions
OSA
Being tested
Educational video intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational video interventionBehavioural

    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.

Study groups in NCT06684717
Study groupRoleWhat they receive
Educational video intervention groupExperimentalThe 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.
Receives: Behavioral: Educational video intervention
Usual care groupNo interventionIn the usual care group, they were routinely advised about the disease and CPAP machine use by sleep medicine doctors and sleep technicians.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start24 Feb 2023
  3. Primary completion17 Feb 2024
  4. Study completion23 Feb 2024

Resources

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
Single group
Model description
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684717
Sponsor's protocol ID
042/2566(IRB2)
Status last verified
Nov 2024
First submitted
10 Nov 2024
Last updated
12 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational video intervention in people with OSA, run by Siriraj Hospital at 1 site in Thailand.

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 1 inclusion and 1 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 12 Nov 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 Thailand. 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?

CPAP adherence rate at 3 weeks after intervention. (time frame: 3 weeks). 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 12 Nov 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in