Clinical trial NCT05055271: Delphi Consensus Excessive Daytime Sleepiness in OSA
Official title: Differential Diagnosis and Management of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea: A Modified Delphi Consensus Panel Report
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
excessive daytime sleepiness
Delphi consensus
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Jazz Pharmaceuticals
First posted: 2021-09-24
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experts in sleep and respiratory medicine from North America and Europe

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

Eligibility criteria: 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.

Primary outcomes:
measure: Consensus
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London (KCL), UK
name: Joerg Steier, PhD
role: STUDY_CHAIR
affiliation: University of California San Diego (UCSD), USA
name: Atul Malhotra, MD
role: STUDY_CHAIR
References:
citation: 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.