Obstructive Sleep ApneaNCT05055271
Delphi Consensus Excessive Daytime Sleepiness in OSA
An observational study of Obstructive Sleep Apnea, run by King's College London at 1 site in United Kingdom.
Trial summary
The objective of this study is to generate expert consensus statements on the differential diagnosis, definition, and management of EDS in patients with OSA who are adequately treated with primary therapy. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 12 Sep 2022
- Phase
- Observational
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Experts in sleep and respiratory medicine from North America and Europe
Who may be able to join
- Members of the panel include experts in sleep and respiratory medicine in North American and Europe.
Who cannot join
- Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Diagnosis and Management of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea: A Modified Delphi Consensus Panel Report
The objective of this study is to generate expert consensus statements on the differential diagnosis, definition, and management of EDS in patients with OSA who are adequately treated with primary therapy.
Read the detailed description
A study will be performed using a modified Delphi process with an international expert panel to generate recommendation statements related to the differential diagnosis and management of patients with residual EDS in OSA (and relevant sub-topics) and to determine the level of agreement for each statement from the panel as a whole. The following topics will be covered:
- EDS: definition, evaluation/assessment, and tools
- Definitions of residual EDS in patients with OSA treated with primary OSA therapy
- Practical recommendations
- Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met (80% agreement).
Part 1: planning and evidence review
- Series of planning sessions with co-chairs and faculty leads
- Literature is reviewed/summarized
- Initial statements will be developed based on evidence Recommendation statements on EDS in OSA will be formulated and rated according to level of agreement on a 5-point Likert scale.
Part 2: Survey to achieve consensus
- Survey, based on the initial statements developed by faculty leads, will be developed to allow for vetting by full faculty group
- At least 3 rounds of review (2 remote and 1 live [virtual]) will be held to achieve consensus on each topic of interest and finalize consensus statements
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, excessive daytime sleepiness, Delphi consensus
- Medical subject headings
- Sleep Apnea, Obstructive, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Delphi panel | The Delphi panel will include 10 international experts in sleep and respiratory medicine. Two panelists will serve as co-chairs and eight panelists will serve as section leads for the major topic areas throughout the process. A series of planning sessions will be conducted with the co-chairs and section leads prior to implementation of the survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating a given statement A+ or A.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Apr 2021
- Primary completion12 Sep 2022
- Study completion12 Sep 2022
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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Principal investigator, Professor Joerg Steier, King's College London
- Investigators
- Joerg Steier, PhD, Study chair, King's College London (KCL), UKAtul Malhotra, MD, Study chair, University of California San Diego (UCSD), USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055271
- Sponsor's protocol ID
- 2021 EDS in OSA Delphi V1.0
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rosenberg R, Schweitzer PK, Steier J, Pepin JL. Residual excessive daytime sleepiness in patients treated for obstructive sleep apnea: guidance for assessment, diagnosis, and management. Postgrad Med. 2021 Sep;133(7):772-783. doi: 10.1080/00325481.2021.1948305. Epub 2021 Jul 22.
PubMed 34292843
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis and Management of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea: A Modified Delphi Consensus Panel Report
- ClinicalTrials.gov ID
- NCT05055271
- Acronym / sponsor ID
- 2021 EDS in OSA Delphi V1.0
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, excessive daytime sleepiness, Delphi consensus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 24 Sep 2021 (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 objective of this study is to generate expert consensus statements on the differential diagnosis, definition, and management of EDS in patients with OSA who are adequately treated with primary therapy.
Detailed description
A study will be performed using a modified Delphi process with an international expert panel to generate recommendation statements related to the differential diagnosis and management of patients with residual EDS in OSA (and relevant sub-topics) and to determine the level of agreement for each statement from the panel as a whole. The following topics will be covered:
- EDS: definition, evaluation/assessment, and tools
- Definitions of residual EDS in patients with OSA treated with primary OSA therapy
- Practical recommendations
- Management Consensus is achieved through iterative rounds of survey and revision to the statements until a pre-determined level of agreement is met (80% agreement).
Part 1: planning and evidence review
- Series of planning sessions with co-chairs and faculty leads
- Literature is reviewed/summarized
- Initial statements will be developed based on evidence Recommendation statements on EDS in OSA will be formulated and rated according to level of agreement on a 5-point Likert scale.
Part 2: Survey to achieve consensus
- Survey, based on the initial statements developed by faculty leads, will be developed to allow for vetting by full faculty group
- At least 3 rounds of review (2 remote and 1 live [virtual]) will be held to achieve consensus on each topic of interest and finalize consensus statements
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delphi panel | – | –The Delphi panel will include 10 international experts in sleep and respiratory medicine. Two panelists will serve as co-chairs and eight panelists will serve as section leads for the major topic areas throughout the process. A series of planning sessions will be conducted with the co-chairs and section leads prior to implementation of the survey. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Experts in sleep and respiratory medicine from North America and Europe
Key inclusion criteria (1 listed)
- Members of the panel include experts in sleep and respiratory medicine in North American and Europe.
Key exclusion criteria (1 listed)
- Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Consensus
Time frame: 6 months
The level of agreement for all statements achieving consensus from the expert panel; consensus is predefined as ≥ 80% of the panel rating a given statement A+ or A.
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 10 Oct 2023.
- Background: PubMed 34292843Rosenberg R, Schweitzer PK, Steier J, Pepin JL. Residual excessive daytime sleepiness in patients treated for obstructive sleep apnea: guidance for assessment, diagnosis, and management. Postgrad Med. 2021 Sep;133(7):772-783. doi: 10.1080/00325481.2021.1948305. Epub 2021 Jul 22.
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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.
Joerg Steier, PhD study chair
King's College London (KCL), UK
Atul Malhotra, MD study chair
University of California San Diego (UCSD), USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by King's College London at 1 site in United Kingdom.
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 10 Oct 2023. 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 Kingdom. 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?
Consensus (time frame: 6 months). 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 NCT05055271, 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 10 Oct 2023.