Evidence map›Paper›PMID 31992406›Full record

ArticleJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2020

Study design considerations for sleep-disordered breathing devices.

Eric A Mann, Srinivas Nandkumar, Nancy Addy, B Gail Demko, Neil S Freedman, M Boyd Gillespie, William Headapohl, Douglas B Kirsch, Barbara A Phillips, Ilene M Rosen and 4 more

Abstract read
In one paragraph

Article in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Eric A MannCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Srinivas NandkumarCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.
Nancy AddyAmerican Academy of Dental Sleep Medicine, Lisle, Illinois.
B Gail DemkoSleep Apnea Dentists of New England, Weston, Massachusetts.
Neil S FreedmanDivision of Pulmonary, Critical Care, Allergy and Immunology, Northshore University Health System, Evanston, Illinois.
M Boyd GillespieDepartment of Otolaryngology-Head and Neck Surgery, University of Tennessee Health Science Center, Memphis, Tennessee.
William HeadapohlAmerican Sleep Apnea Association, Washington, DC.
Douglas B KirschCarolinas HealthCare System Sleep Medicine, Charlotte, North Carolina.
Barbara A PhillipsDepartment of Medicine, University of Kentucky College of Medicine, Lexington, Kentucky.
Ilene M RosenDepartment of Medicine, Perelman School of Medicine, Philadelphia, Pennsylvania.
Logan D SchneiderPsychiatry and Behavioral Sciences, Stanford Center for Sleep Sciences and Medicine, Redwood City, California.
Carl J StepnowskyAmerican Sleep Apnea Association, Washington, DC.
Kathleen L YaremchukDepartment of Otolaryngology Head and Neck Surgery, Henry Ford Health System, Detroit, Michigan.
Malvina B EydelmanCenter for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

None: In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new and better diagnostic and therapeutic options. To facilitate the development and availability of innovative, safe and effective SDB medical device technologies for patients in the United States, the US Food and Drug Administration collaborated with six SDB-related professional societies and a consumer advocacy organization to convene a public workshop focused on clinical investigations of SDB devices. Sleep medicine experts discussed appropriate definitions of terms used in the diagnosis and treatment of SDB, the use of home sleep testing versus polysomnography, clinical trial design issues in studying SDB devices, and current and future trends in digital health technologies for diagnosis and monitoring SDB. The panel's breadth of clinical expertise and experience across medical specialties provided useful and important insights regarding clinical trial designs for SDB devices.

Indexed as

Sleep Apnea SyndromesAdultHumansPolysomnographyResearch DesignSleepclinical trialpolysomnographysleep apnea syndromes

Identifiers

PMID31992406
PMCPMC7075096

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.