Siriraj Hospital, Mahidol University
Bangkok, 10700, Thailand
NCT Number: NCT06684717
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Bangkok, 10700, Thailand
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
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 weeks
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.
Siriraj Hospital
Other
Using an Educational Video to Enhance Adherence of Continuous Positive Pressure Therapy in Thai Obstructive Sleep Apnea Patients: a Randomised Controlled Trial
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