Delphi Consensus Excessive Daytime Sleepiness in OSA

NCT05055271 | Completed

• 1 other identifier: 2021 EDS in OSA Delphi V1.0
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea; excessive daytime sleepiness; Delphi consensus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Experts in sleep and respiratory medicine from North America and Europe

You may qualify if:

• Members of the panel include experts in sleep and respiratory medicine in North American and Europe.

You may not qualify if:

• Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded.

Sponsors & Collaborators

• King's College London: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

King's College London

London, SE1 7EH, United Kingdom

Location

Related 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.

  PMID: 34292843 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Joerg Steier, PhD

  King's College London (KCL), UK

  STUDY CHAIR

• Atul Malhotra, MD

  University of California San Diego (UCSD), USA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Respiratory and Sleep Medicine

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 24, 2021
• Study Start: April 1, 2021
• Primary Completion: September 12, 2022
• Study Completion: September 12, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

GB (1)