Delphi Consensus Excessive Daytime Sleepiness in OSA

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT05055271
• Lead Sponsor: King's College London

Brief 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.

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 Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-24
• Primary Completion: 2022-09-12
• Study Completion: 2022-09-12
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consensus	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.

Trial Locations

Locations (1)

King's College London; 🇬🇧 London, United Kingdom