Evidence map›Paper›PMID 39589391›Full record

Trial reportSleep2025

A randomized dose finding study of combination dronabinol and acetazolamide for the treatment of obstructive sleep apnea.

Jennifer Walsh, Timothy Rankin, Sumit Mehra, Matthew T Naughton, Teanau Roebuck, Elizabeth McDermott, Andreas Pattichis, Rafael Smith, Rosemarie Walsh, Mark Bleackley and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Sleep, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Trial
  2. Pharmacotherapy in obstructive sleep apnoea: a clinical guide.Sleep & breathing = Schlaf & Atmung · 2026
    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

12 authors.

Jennifer WalshCentre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Western Australia, Australia.ORCID 0000-0003-3950-6079
Timothy RankinCentre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Western Australia, Australia.
Sumit MehraCentre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Western Australia, Australia.
Matthew T NaughtonDepartment of Respiratory Medicine, Sleep Medicine Service, Alfred Health, Melbourne, Victoria, Australia.
Teanau RoebuckDepartment of Respiratory Medicine, Sleep Medicine Service, Alfred Health, Melbourne, Victoria, Australia.
Elizabeth McDermottDepartment of Respiratory Medicine, Sleep Medicine Service, Alfred Health, Melbourne, Victoria, Australia.
Andreas PattichisEpilepsy and Neuropharmacology Clinical Trials Unit, Alfred Brain, Alfred Health, Melbourne, Victoria, Australia.
Rafael SmithEpilepsy and Neuropharmacology Clinical Trials Unit, Alfred Brain, Alfred Health, Melbourne, Victoria, Australia.
Rosemarie WalshIncannex Healthcare Limited, Melbourne, Victoria, Australia.
Mark BleackleyIncannex Healthcare Limited, Melbourne, Victoria, Australia.
Kathleen MaddisonCentre for Sleep Science, School of Human Sciences, University of Western Australia, Perth, Western Australia, Australia.
Terence J O'BrienEpilepsy and Neuropharmacology Clinical Trials Unit, Alfred Brain, Alfred Health, Melbourne, Victoria, Australia.

Funding

Incannex Healthcare Ltd
6 · The paper itself

Abstract

STUDY

objectivesCurrent treatments for obstructive sleep apnea (OSA) are ineffective or not tolerated in a proportion of patients. Other therapeutic options are needed and pharmaceuticals may provide an alternative. This randomized, double-blind, placebo-controlled, crossover study examined the effect of a combination of acetazolamide and dronabinol (IHL-42X) at low, medium, and high doses on OSA severity.

methodsParticipants with OSA (apnea-hypopnea index; AHI ≥15 events/hour) received 1 week of IHL-42X at each of three doses and placebo, each separated by a 1-week washout. The change from baseline in AHI, oxygen desaturation index (ODI), Epworth sleepiness score (ESS), and mood (profile of mood states) on the final night of each treatment arm relative to the change from baseline to placebo were the major endpoints. Adverse events (AEs) were monitored throughout.

resultsTen of 11 participants completed the final night of at least one treatment arm. IHL-42X demonstrated a greater reduction in AHI from baseline compared with placebo (low, -19.7 ± 27.1; medium, -17.5 ± 23.3; high, -16.4 ± 23.8 vs. placebo, -2.8 ± 21.0 events/hour; all p < .05). The change from baseline in ODI3% was greater for the medium IHL-42X dose when compared with placebo (-15.4 ± 19.0 vs. placebo, -2.8 ± 21.0 events/hour; p < .05) but not the low or high doses (low, -15.2 ± 24.8; high, -8.3 ± 13.2 events/hour). IHL-42X did not change ESS or mood. No serious AEs occurred; however, 35 mild-moderate possibly, probably, or treatment-related AEs occurred during IHL-42X dosing and 5 occurred during placebo.

conclusionsOne week of nightly IHL-42X at low, medium, and high doses was well tolerated, safe, and associated with significant reductions in OSA severity.

Indexed as

AcetazolamideDronabinolSleep Apnea, ObstructiveAdultAgedCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedPolysomnographyTreatment OutcomeAcetazolamideDronabinolacetazolamideapnea–hypopnea indexcannabinoidsoxygen desaturation index

Identifiers

PMID39589391
PMCPMC11985395

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.