Delphi Consensus Excessive Daytime Sleepiness in OSA

October 5, 2023 updated by: Professor Joerg Steier, King's College London

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.

Study Overview

Status

Completed

Conditions

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:

  1. EDS: definition, evaluation/assessment, and tools
  2. Definitions of residual EDS in patients with OSA treated with primary OSA therapy
  3. Practical recommendations
  4. 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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 7EH
        • King's College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Experts in sleep and respiratory medicine from North America and Europe

Description

Inclusion Criteria:

  • Members of the panel include experts in sleep and respiratory medicine in North American and Europe.

Exclusion Criteria:

  • Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Jazz Pharmaceuticals

Investigators

  • Study Chair: Joerg Steier, PhD, King's College London (KCL), UK
  • Study Chair: Atul Malhotra, MD, University of California San Diego (UCSD), USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

September 12, 2022

Study Completion (Actual)

September 12, 2022

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021 EDS in OSA Delphi V1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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