Evidence map›Paper›PMID 36003019›Full record

Trial reportJournal of sleep research2023

Armodafinil to reduce the sleepiness related side-effects of sleep restriction therapy being used to treat insomnia disorder: An open label clinical trial pilot study compared with historical controls.

Daniel J Judge, Christopher B Miller, Delwyn J Bartlett, Ibrahim Jomaa, Keith K W Wong, Bandana Saini, Caitlin R Semsarian, Colin A Espie, Simon D Kyle, Ron R Grunstein and 2 more

Open access · hybridAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of sleep research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 30% of its field
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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Trial
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 at 2 institutions in 2 countries.

Daniel J JudgeNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.
Christopher B MillerNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-2936-7717
Delwyn J BartlettNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.
Ibrahim JomaaNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.
Keith K W WongNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.
Bandana SainiNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.
Caitlin R SemsarianNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0001-8691-0248
Colin A EspieNuffield Department of Clinical Neurosciences and Sleep & Circadian Neuroscience Institute, University of Oxford, Oxford, UK.ORCID 0000-0002-1294-8734
Simon D KyleNuffield Department of Clinical Neurosciences and Sleep & Circadian Neuroscience Institute, University of Oxford, Oxford, UK.
Ron R GrunsteinNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.
Brendon J YeeNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.
Nathaniel S MarshallNeuroSleep and Woolcock Institute of Medical Research, University of Sydney, Sydney, New South Wales, Australia.ORCID 0000-0002-9014-1397
The University of Sydney · AUUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sleep restriction therapy (SRT) is an effective stand-alone behavioural intervention for insomnia disorder. However, its daytime side effects, particularly sleepiness, may be troubling for patients and/or may be a necessary part of the patient's treatment journey. This pilot trial aims to explore the potential benefit of armodafinil, a wakefulness promoter. Patients were treated with SRT with open label adjunctive armodafinil (150 mg/day). Thirty-three patients from previous studies that have undergone exactly the same SRT intervention acted as controls. The primary outcome measure was the insomnia severity index (ISI), and secondary outcomes were the Epworth sleepiness scale, sleep restriction adherence scale (SRAS), and safety from baseline through to 12 weeks. We recruited 25 patients into the trial. Data for the primary end point (ISI at 12 weeks) was available for 20 of the participants. The baseline insomnia severity index was 20.2 (SD 3.3) and decreased to 9.1 (SE 1.1), with no change, to 10.2 and 11.2 at weeks 6 and 12 respectively (all p > 0.05 compared with baseline). The insomnia severity index values for armodafinil patients were statistically inferior to historical controls at the primary time point of 12 weeks (11.2 vs. 6.7, p < 0.01). Sleep restriction therapy plus armodafinil treatment was associated with frequent minor side effects but was generally safe and acceptable to patients. Sleep restriction therapy was associated with a robust clinical response in the insomnia severity index values for insomnia patients. Based upon historical control data, armodafinil does not appear to have beneficial adjunctive effects in addition to sleep restriction therapy alone.

Indexed as

ModafinilSleepinessSleep Initiation and Maintenance DisordersHumansPilot ProjectsTreatment OutcomeWakefulnessModafiniladverse eventsfatigueiatrogenicmodafinilsleepy

Identifiers

PMID36003019
PMCPMC10909410
OpenAlexW4293105701

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.