Evidence map›Paper›PMID 41202295›Full record

ArticleJMIR research protocols2025

Acute Adenosine Receptor Antagonism in Combination With Acute Intermittent Hypoxia to Promote Breathing Plasticity in Amyotrophic Lateral Sclerosis: Protocol for a Randomized, Double-Blinded, Placebo-Controlled Trial.

Priscila Sales de Campos, May Smith-Hublou, Wendy L Olsen, Wagner Souza Leite, James P Wymer, Nicholas J Napoli, Alicia K Vose, Michael T Pulley, Gordon S Mitchell, Barbara K Smith

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05377424 (Acute Adenosine Receptor Antagonism to Promote Breathing Plasticity in ALS), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05377424 phase1 / phase2active not recruitingnot on this map

Acute Adenosine Receptor Antagonism to Promote Breathing Plasticity in ALS

TypeinterventionalSponsorUniversity of FloridaRan2022 to 2026Enrolled40ConditionsALSArmsConsume 20mg of istradefylline, Low Oxygen therapy, Placebo counterpart to the istradefylline drug, SHAM counterpart to low oxygen therapy.
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

10 authors.

Priscila Sales de CamposBreathing Research and Therapeutics Center, University of Florida, Gainesville, FL, United States.ORCID 0000-0003-0194-7135
May Smith-HublouBreathing Research and Therapeutics Center, University of Florida, Gainesville, FL, United States.ORCID 0000-0001-8797-4884
Wendy L OlsenBreathing Research and Therapeutics Center, University of Florida, Gainesville, FL, United States.ORCID 0000-0002-7607-8096
Wagner Souza LeiteBreathing Research and Therapeutics Center, University of Florida, Gainesville, FL, United States.ORCID 0000-0001-5716-125X
James P WymerMcKnight Brain Institute, University of Florida, Gainesville, FL, United States.ORCID 0000-0003-0809-2977
Nicholas J NapoliBreathing Research and Therapeutics Center, University of Florida, Gainesville, FL, United States.ORCID 0000-0002-9071-3965
Alicia K VoseBreathing Research and Therapeutics Center, University of Florida, Gainesville, FL, United States.ORCID 0000-0001-5502-266X
Michael T PulleyCollege of Medicine-Jacksonville, Department of Neurology, University of Florida, Jacksonville, FL, United States.ORCID 0000-0003-1879-725X
Gordon S MitchellBreathing Research and Therapeutics Center, University of Florida, Gainesville, FL, United States.ORCID 0000-0002-8489-1861
Barbara K SmithBreathing Research and Therapeutics Center, University of Florida, Gainesville, FL, United States.ORCID 0000-0002-3255-7036

Funding

Breathing Research and Therapeutics (BREATHE)T32HL134621 · NHLBI · UNIVERSITY OF FLORIDA · PI Gordon S. Mitchell · 2017 to 2026
$3.4M
ALS Association 22-CTA-611NHLBI NIH HHS T32 HL134621
6 · The paper itself

Abstract

backgroundRespiratory impairment is a major concern in amyotrophic lateral sclerosis (ALS), shortening survival and lowering quality of life. One therapy with promise to delay respiratory decline in ALS is acute intermittent hypoxia (AIH), consisting of alternating periods of breathing mildly hypoxic (9%-12% O

objectiveWe propose to investigate a therapeutic strategy to delay breathing compromise in those living with ALS by combining a selective adenosine 2A (A

methodsWe propose to evaluate resting breathing, respiratory strength, and participant-reported symptoms in adults living with ALS after combined istradefylline plus AIH. A mixed within- and between-participant study design incorporates 4 test sessions, separated by approximately 2 weeks (±5 days). Testing conditions include single sessions of AIH + istradefylline, AIH + placebo, sham AIH (ie, normoxia) + placebo, and sham AIH + istradefylline. Safety and feasibility will be characterized using the rate of adverse events, changes in vital signs, and participant-reported breathing sensations (Aim 1). Neuroplasticity of breathing and motor function will be evaluated as changes in resting breathing, voluntary respiratory strength, respiratory control, and maximal pinch force (Aim 2).

resultsAs of January 2025, with a target sample of 16 participants in each group, 10 participants with ALS and 5 control participants completed study procedures. Recruiting is ongoing, and the final participant will complete the study by December 2025. Publication of results is expected by the end of 2026.

conclusionsThese aims will provide crucial data regarding the preliminary safety and feasibility of this paired intervention and help optimize therapeutic AIH as a rehabilitation strategy, thereby guiding further research concerning this novel treatment for ALS.

trial registrationClinicalTrials.gov NCT05377424; https://clinicaltrials.gov/study/NCT05377424. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/76105.

Indexed as

Amyotrophic Lateral SclerosisHypoxiaNeuronal PlasticityPurinergic P1 Receptor AntagonistsRespirationAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPurinesRandomized Controlled Trials as TopicistradefyllinePurinergic P1 Receptor AntagonistsPurinesacute intermittent hypoxiaadenosine A2A receptoramyotrophic lateral sclerosisneuronal plasticityrespiration

Identifiers

PMID41202295
PMCPMC12639348

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.