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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
- Enrolled patients were informed about the study and asked for consent form on the date of appointment after PSG study. 5
- 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.
- Random permuted blocks design was used to randomly assigned each participant into video education intervention and usual care group.
- 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.
- In the usual care group, they were routinely advised about the disease and CPAP machine use by sleep medicine doctors and sleep technicians.
- After prescribed with CPAP therapy, all patients were appointed to return at 3 weeks.
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted12 Nov 2024
- Study start24 Feb 2023
- Primary completion17 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jindapa Srikajon, Siriraj Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Educational Video to Enhance Adherence of Continuous Positive Pressure Therapy in Thai Obstructive Sleep Apnea Patients: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06684717
- Acronym / sponsor ID
- 042/2566(IRB2)
- Conditions
- OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 12 Nov 2024 (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 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.
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
- Enrolled patients were informed about the study and asked for consent form on the date of appointment after PSG study. 5
- 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.
- Random permuted blocks design was used to randomly assigned each participant into video education intervention and usual care group.
- 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.
- In the usual care group, they were routinely advised about the disease and CPAP machine use by sleep medicine doctors and sleep technicians.
- After prescribed with CPAP therapy, all patients were appointed to return at 3 weeks.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Educational video intervention group | Experimental | Behavioral: Educational video interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Participants who were not CPAP naïve, had central sleep apnea, had comorbidities that were contraindicated for CPAP therapy or denied using CPAP.
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 |
|---|---|---|
| Educational video interventionA 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. | Behavioural | Educational video intervention group |
Primary outcome
CPAP adherence rate at 3 weeks after intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.