Delphi Consensus Excessive Daytime Sleepiness in OSA

Sponsor

King's College London (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05055271

Collaborator

Jazz Pharmaceuticals (Industry)

Enrollment

Location

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea

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

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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.