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Completed

NCT Number: NCT05055271

Delphi Consensus Excessive Daytime Sleepiness in OSA

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College London

London, SE1 7EH, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Jazz Pharmaceuticals

Registry information

Official study title

Differential Diagnosis and Management of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea: A Modified Delphi Consensus Panel Report

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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