Delphi Consensus Excessive Daytime Sleepiness in OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055271
• Other study ID #: 2021 EDS in OSA Delphi V1.0
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: September 12, 2022

Study information

• Verified date: October 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 12, 2022
• Est. primary completion date: September 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Disorders of Excessive Somnolence
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleepiness

Locations

Country	Name	City	State
United Kingdom	King's College London	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Jazz Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consensus	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.	6 months