ClinicalTrials.gg
CompletedNCT05055271Updated Oct 10, 2023

Delphi Consensus Excessive Daytime Sleepiness in OSA

An observational study in Obstructive Sleep Apnea, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by King's College London · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 54 studies in Sleep Apnea, Obstructive with a site in United Kingdom — 9 open to participants now, 13 under way, none of them phase 3. Sleep Apnea, Obstructive · United Kingdom.

Enrollment
27th of 28
10 · median 102
Started
2021
with 3 others
Observational
28 of 54
6 open now
Registered
39th of 54
by date
Lead sponsor
5 of 54
King's College London

Among the 54 studies in Sleep Apnea, Obstructive with a site in United Kingdom, this one is the 27th largest by enrollment of the 28 observational ones that give a count, is one of 4 that started in 2021, is one of 28 observational ones, and was the 39th registered.

Sleep Apnea, Obstructive

2,243 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

Browse Sleep Apnea, Obstructive studies →

Open to participants now

9 of the 54 studies in Sleep Apnea, Obstructive with a site in United Kingdom are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 313 Sleep Apnea, Obstructive studies recruiting now, 146 (47%) set no upper age limit and 124 (40%) stop at 75 or younger; 52 take children under 18; 65 take healthy volunteers.

This study: 19 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 54 studies in Sleep Apnea, Obstructive with a site in United Kingdom, or all of them as a file.
02

Study 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.

Read the 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
03

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Obstructive sleep apnea
  • excessive daytime sleepiness
  • Delphi consensus
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Experts in sleep and respiratory medicine from North America and Europe

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Panelists who were not able to commit to all rounds of the modified Delphi process will be excluded.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: 6 months

07

Study locations

1 site
  • King's College London
    London, SE1 7EH, United Kingdom
08

References and documents

Publications

  • 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. PubMed 34292843 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Sep 2022, 17 months.

Of 258 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 61. This study's 17 months is below that.

Counting every sponsor, half of 294 studies reached it within 28 months; a quarter within 14 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2021
First posted
Sep 24, 2021
StartActual
Apr 1, 2021
Primary completionActual
Sep 12, 2022
CompletionActual
Sep 12, 2022
Last update
Oct 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05055271
Responsible party
Professor Joerg Steier (Professor of Respiratory and Sleep Medicine, King's College London) — Principal investigator
First posted
Sep 24, 2021
Start date
Apr 1, 2021
Primary completion
Sep 12, 2022
Completion
Sep 12, 2022
Last update
Oct 10, 2023

Study contacts

Joerg Steier, PhD
study chair · King's College London (KCL), UK
Atul Malhotra, MD
study chair · University of California San Diego (UCSD), USA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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