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Delphi Consensus Excessive Daytime Sleepiness in OSA

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05055271
Enrollment
10
Registered
2021-09-24
Start date
2021-04-01
Completion date
2022-09-12
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea, excessive daytime sleepiness, Delphi consensus

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

Interventions

None listed

Sponsors

Jazz Pharmaceuticals
CollaboratorINDUSTRY
King's College London
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Consensus6 monthsThe 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026