Obstructive Sleep ApneaeDecide2RestNCT03138993
Improving Older Adults' Decision Making for OSAT
A study testing Patient decision aid and General sleep education in people with Obstructive Sleep Apnea, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Patient decision aid and General sleep education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2017to 30 Nov 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 60 years
- diagnosed with obstructive sleep apnea on a sleep study
- able to read English-language newspaper text (if needed, using contact lens/glasses)
- able to write words in a paper booklet
- scheduled for a sleep clinic appointment with a UCLA sleep provider
- able to attend a sleep educational session prior to sleep clinic appointment
Who cannot join
- unable to provide informed consent
- dementia
- mild cognitive impairment diagnosis or Mini-Cog score < 3
- treated for obstructive sleep apnea for > 30 days prior to scheduled sleep education intervention
- severe physical or mental illness (e.g., hospitalized within past 7 days prior to scheduled sleep education intervention, substance abuse within 90 days of sleep education intervention)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Improving Older Adults' Decision Making for Obstructive Sleep Apnea Treatment (Phase 3)
This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will use a patient decision aid, while the other half will receive general information about sleep.
Read the detailed description
Patient decision aids are one strategy for helping older adults make informed decisions about treatments. Patient decision aids improve patients' knowledge about therapies and encourage them to actively weigh the risks and benefits of each therapy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Patient decision aid, General sleep education
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient decision aidBehavioural
Web-based patient decision aid plus a paper workbook.
General sleep educationBehavioural
Web-based information about sleep plus a paper workbook
| Study group | Role | What they receive |
|---|---|---|
| Patient decision aid | Active comparator | Not described Receives: Behavioral: Patient decision aid |
| General sleep education | Sham comparator | Not described Receives: Behavioral: General sleep education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
The investigators will measure recruitment rates for our recruitment strategies
Measured: Through study completion, an average of 1 year
Enrollment rates
The investigators will measure enrollment rates
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
The length of time for completing the intervention session
The investigators will measure the length of time for completing the intervention session
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start22 May 2017
- Primary completion29 May 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 California, Los AngelesThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Constance Fung, MD, MSHS, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138993
- Sponsor's protocol ID
- 16001482
- Acronym
- eDecide2Rest
- Status last verified
- Sep 2019
- First submitted
- 14 Feb 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fung CH, Martin JL, Liang LJ, Hays RD, Col N, Patterson ES, Josephson K, Mitchell MN, Sanchez MC, Aysola R, Song Y, Dzierzewski JM, Huang D, Zeidler M, Alessi C. Efficacy of a patient decision aid for improving person-centered decision-making by older adults with obstructive sleep apnea. J Clin Sleep Med. 2021 Feb 1;17(2):121-128. doi: 10.5664/jcsm.8798.
PubMed 32955013
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Older Adults' Decision Making for Obstructive Sleep Apnea Treatment (Phase 3)
- ClinicalTrials.gov ID
- NCT03138993
- Acronym / sponsor ID
- eDecide2Rest / 16001482
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 3 May 2017 (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.
This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will use a patient decision aid, while the other half will receive general information about sleep.
Detailed description
Patient decision aids are one strategy for helping older adults make informed decisions about treatments. Patient decision aids improve patients' knowledge about therapies and encourage them to actively weigh the risks and benefits of each therapy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient decision aid | Active comparator | Behavioral: Patient decision aid |
| General sleep education | Sham comparator | Behavioral: General sleep education |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age >= 60 years
- diagnosed with obstructive sleep apnea on a sleep study
- able to read English-language newspaper text (if needed, using contact lens/glasses)
- able to write words in a paper booklet
- scheduled for a sleep clinic appointment with a UCLA sleep provider
Key exclusion criteria (5 listed)
- unable to provide informed consent
- dementia
- mild cognitive impairment diagnosis or Mini-Cog score < 3
- treated for obstructive sleep apnea for > 30 days prior to scheduled sleep education intervention
- severe physical or mental illness (e.g., hospitalized within past 7 days prior to scheduled sleep education intervention, substance abuse within 90 days of sleep education intervention)
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 |
|---|---|---|
| Patient decision aidWeb-based patient decision aid plus a paper workbook. | Behavioural | Patient decision aid |
| General sleep educationWeb-based information about sleep plus a paper workbook | Behavioural | General sleep education |
Primary outcome
Recruitment rates
Time frame: Through study completion, an average of 1 year
The investigators will measure recruitment rates for our recruitment strategies
Enrollment rates
Time frame: Through study completion, an average of 1 year
The investigators will measure enrollment rates
1 secondary outcome
The length of time for completing the intervention session
Time frame: Through study completion, an average of 1 year
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 26 Sep 2019.
- Derived from this study: PubMed 32955013Fung CH, Martin JL, Liang LJ, Hays RD, Col N, Patterson ES, Josephson K, Mitchell MN, Sanchez MC, Aysola R, Song Y, Dzierzewski JM, Huang D, Zeidler M, Alessi C. Efficacy of a patient decision aid for improving person-centered decision-making by older adults with obstructive sleep apnea. J Clin Sleep Med. 2021 Feb 1;17(2):121-128. doi: 10.5664/jcsm.8798.
- 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 Patient decision aid and General sleep education in people with Obstructive Sleep Apnea, run by University of California, Los Angeles 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 6 inclusion and 5 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 26 Sep 2019. 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. Some participants in this study may receive a placebo. 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?
Recruitment rates (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 NCT03138993, which also lists 1 linked publication.
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 26 Sep 2019.