Delphi Consensus Excessive Daytime Sleepiness in OSA

NCT ID: NCT05055271

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-09-12

Brief Summary

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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

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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

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jazz Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Professor Joerg Steier

Professor of Respiratory and Sleep Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joerg Steier, PhD

Role: STUDY_CHAIR

King's College London (KCL), UK

Atul Malhotra, MD

Role: STUDY_CHAIR

University of California San Diego (UCSD), USA

Locations

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King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 34292843 (View on PubMed)

Other Identifiers

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2021 EDS in OSA Delphi V1.0

Identifier Type: -

Identifier Source: org_study_id

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