Obstructive Sleep ApneaSAVE-CPAPNCT02553694
Sleep Apnea Video Education for CPAP (SAVE-CPAP)
A study testing Enhanced education, Usual education and Usual follow up in people with Obstructive Sleep Apnea, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to determine how satisfied patients are when undergoing an overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what factors affect obstructive sleep apnea (OSA) treatment use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Enhanced education, Usual education and Usual follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged > 18 years of age who are referred to the University of Chicago sleep laboratory for split-night polysomnography by a non-sleep physician and who have a consultation appointment with a sleep physician following the appointment
- Have not had prior contact with a sleep physician or prior exposure to CPAP therapy.
- Exclusion Criteria: Subjects will be excluded for any of the following characteristics: -Non-English speaking
- Illiterate
- Sleep study is negative for sleep apnea (apnea-hypopnea index < 5 events/hr)
- Subject does not undergo CPAP titration during the in-laboratory polysomnogram
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- Subject does not have a working telephone number
- Poor eyesight or hearing
- Dementia
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Short Educational Video on OSA Patient Satisfaction, Knowledge and Outcomes
The purpose of this study is to determine how satisfied patients are when undergoing an overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what factors affect obstructive sleep apnea (OSA) treatment use.
Read the detailed description
The effects of educational interventions on subject compliance, satisfaction, and knowledge of their condition will be examined through the use of video vs pamphlet and MD vs staff contact for follow-up visit reminder.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Enhanced education, Usual education, Usual follow up, Enhanced follow up
- Keywords
- OSA, Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced educationOther
Investigator created video to help educate subject before the in-laboratory split night polysomnogram. The subject will watch the short video immediately prior to the initiation of the in-laboratory polysomnogram.
Usual educationOther
Usual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets
Usual follow upOther
MD will follow up by phone after the in-laboratory split night polysomnogram
Enhanced follow upOther
Sleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram
| Study group | Role | What they receive |
|---|---|---|
| Enhanced education and Enhanced follow up | Experimental | Subjects will watch a short video and will be contacted by an MD by phone Receives: Other: Enhanced education; Other: Usual follow up |
| Usual education and Usual follow up | Active comparator | Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and will be contacted by a sleep center staff member by phone Receives: Other: Usual education; Other: Enhanced follow up |
| Enhanced education and Usual follow up | Experimental | Subjects will watch a short video immediately prior to the initiation of the in-laboratory polysomnogram and will be contacted by sleep center non-MD staff member by phone Receives: Other: Enhanced education; Other: Enhanced follow up |
| Usual education with Enhanced follow up | Experimental | Standard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and contacted by an MD by phone Receives: Other: Usual education; Other: Usual follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Therapy Adherence
Subject use of CPAP device will be monitored electronically. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to in-laboratory split night polysomnogram (sleep study) and initiation of CPAP therapy, and CPAP adherence rates of the two groups will be compared and reported.
Measured: 30 days post in-lab split night polysomnogram
Secondary outcomes (4)
Subject compliance with sleep clinic appointment
Subjects will be randomized to receive a reminder call for follow up clinic appointment either from MD or staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.
Measured: within 3 months after the in-laboratory split night polysomnogram
Patient Knowledge About Sleep Apnea and CPAP Therapy
Subjects will be administered 2 questionnaires which measure knowledge about their condition, both before and after the in-laboratory split night polysomnogram (sleep study). The scores of the two questionnaires will be combined for both test administrations. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to sleep study and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.
Measured: 1 day post in-laboratory split night polysomnogram
Patient Satisfaction With the in-laboratory split night polysomnogram
Subjects will be administered 2 questionnaires which measure their mood and well-being, both before and after the in-laboratory split night polysomnogram. The questionnaires will be scored and the scores for each subject will be combined at both testing administrations. On the night of the in-laboratory polysomnogram subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to the initiation of the polysomnogram and initiation of CPAP therapy, and the change in the combined questionnaire scores of the two groups will be compared and reported.
Measured: 1 day post in-laboratory split night polysomnogram
CPAP Therapy Adherence
Subjects will be randomized to receive a reminder call for follow up sleep clinic appointment either from MD or non-MD sleep center staff, and the compliance rates of the two groups will be compared based on call type and educational intervention type.
Measured: 1 month post sleep clinic visit or the date of the missed sleep clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Babak Mokhlesi, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553694
- Sponsor's protocol ID
- IRB14-0198
- Acronym
- SAVE-CPAP
- Status last verified
- Mar 2017
- First submitted
- 5 Aug 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kohli P, Balachandran JS, Malhotra A. Obstructive sleep apnea and the risk for cardiovascular disease. Curr Atheroscler Rep. 2011 Apr;13(2):138-46. doi: 10.1007/s11883-011-0161-8.
PubMed 21253882Metabolic disorders associated with obstructive sleep apnea in adults. Adv Cardiol. 2011;46:67-138. doi: 10.1159/000325106. Epub 2011 Oct 13.
PubMed 22005190Balachandran JS, Yu X, Wroblewski K, Mokhlesi B. A brief survey of patients' first impression after CPAP titration predicts future CPAP adherence: a pilot study. J Clin Sleep Med. 2013 Mar 15;9(3):199-205. doi: 10.5664/jcsm.2476.
PubMed 23493772Guralnick AS, Balachandran JS, Szutenbach S, Adley K, Emami L, Mohammadi M, Farnan JM, Arora VM, Mokhlesi B. Educational video to improve CPAP use in patients with obstructive sleep apnoea at risk for poor adherence: a randomised controlled trial. Thorax. 2017 Dec;72(12):1132-1139. doi: 10.1136/thoraxjnl-2017-210106. Epub 2017 Jun 30.
PubMed 28667231
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Short Educational Video on OSA Patient Satisfaction, Knowledge and Outcomes
- ClinicalTrials.gov ID
- NCT02553694
- Acronym / sponsor ID
- SAVE-CPAP / IRB14-0198
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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 purpose of this study is to determine how satisfied patients are when undergoing an overnight polysomnogram (sleep study), what their knowledge about sleep apnea is, and what factors affect obstructive sleep apnea (OSA) treatment use.
Detailed description
The effects of educational interventions on subject compliance, satisfaction, and knowledge of their condition will be examined through the use of video vs pamphlet and MD vs staff contact for follow-up visit reminder.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enhanced education and Enhanced follow up | Experimental | Other: Enhanced education, Other: Usual follow upSubjects will watch a short video and will be contacted by an MD by phone |
| Usual education and Usual follow up | Active comparator | Other: Usual education, Other: Enhanced follow upStandard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and will be contacted by a sleep center staff member by phone |
| Enhanced education and Usual follow up | Experimental | Other: Enhanced education, Other: Enhanced follow upSubjects will watch a short video immediately prior to the initiation of the in-laboratory polysomnogram and will be contacted by sleep center non-MD staff member by phone |
| Usual education with Enhanced follow up | Experimental | Other: Usual education, Other: Usual follow upStandard education by American Academy of Sleep Medicine (AASM)- created educational pamphlets and contacted by an MD by phone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged > 18 years of age who are referred to the University of Chicago sleep laboratory for split-night polysomnography by a non-sleep physician and who have a consultation appointment with a sleep physician following the appointment
- Have not had prior contact with a sleep physician or prior exposure to CPAP therapy.
- Exclusion Criteria: Subjects will be excluded for any of the following characteristics: -Non-English speaking
- Illiterate
- Sleep study is negative for sleep apnea (apnea-hypopnea index < 5 events/hr)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Enhanced educationInvestigator created video to help educate subject before the in-laboratory split night polysomnogram. The subject will watch the short video immediately prior to the initiation of the in-laboratory polysomnogram. | Other | Enhanced education and Enhanced follow up, Enhanced education and Usual follow up |
| Usual educationUsual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets | Other | Usual education and Usual follow up, Usual education with Enhanced follow up |
| Usual follow upMD will follow up by phone after the in-laboratory split night polysomnogram | Other | Enhanced education and Enhanced follow up, Usual education with Enhanced follow up |
| Enhanced follow upSleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram | Other | Enhanced education and Usual follow up, Usual education and Usual follow up |
Primary outcome
CPAP Therapy Adherence
Time frame: 30 days post in-lab split night polysomnogram
Subject use of CPAP device will be monitored electronically. Subjects will be randomized to educational intervention of either viewing a video or reading a pamphlet prior to in-laboratory split night polysomnogram (sleep study) and initiation of CPAP therapy, and CPAP adherence rates of the two groups will be compared and reported.
4 secondary outcomes
Subject compliance with sleep clinic appointment
Time frame: within 3 months after the in-laboratory split night polysomnogram
Patient Knowledge About Sleep Apnea and CPAP Therapy
Time frame: 1 day post in-laboratory split night polysomnogram
Patient Satisfaction With the in-laboratory split night polysomnogram
Time frame: 1 day post in-laboratory split night polysomnogram
CPAP Therapy Adherence
Time frame: 1 month post sleep clinic visit or the date of the missed sleep clinic visit
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 3 Mar 2017.
- Background: PubMed 21253882Kohli P, Balachandran JS, Malhotra A. Obstructive sleep apnea and the risk for cardiovascular disease. Curr Atheroscler Rep. 2011 Apr;13(2):138-46. doi: 10.1007/s11883-011-0161-8.
- Background: PubMed 22005190Metabolic disorders associated with obstructive sleep apnea in adults. Adv Cardiol. 2011;46:67-138. doi: 10.1159/000325106. Epub 2011 Oct 13.
- Background: PubMed 23493772Balachandran JS, Yu X, Wroblewski K, Mokhlesi B. A brief survey of patients' first impression after CPAP titration predicts future CPAP adherence: a pilot study. J Clin Sleep Med. 2013 Mar 15;9(3):199-205. doi: 10.5664/jcsm.2476.
- Derived from this study: PubMed 28667231Guralnick AS, Balachandran JS, Szutenbach S, Adley K, Emami L, Mohammadi M, Farnan JM, Arora VM, Mokhlesi B. Educational video to improve CPAP use in patients with obstructive sleep apnoea at risk for poor adherence: a randomised controlled trial. Thorax. 2017 Dec;72(12):1132-1139. doi: 10.1136/thoraxjnl-2017-210106. Epub 2017 Jun 30.
- 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.
Babak Mokhlesi, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced education, Usual education and Usual follow up in people with Obstructive Sleep Apnea, run by University of Chicago at 1 site in United States.
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 9 inclusion and 0 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 3 Mar 2017. 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 United States. 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 Therapy Adherence (time frame: 30 days post in-lab split night polysomnogram). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02553694, which also lists 4 linked publications.
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 3 Mar 2017.