Evidence map›Paper›PMID 22003345›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2011

EEG power spectra response to a 4-h phase advance and gaboxadol treatment in 822 men and women.

Junshui Ma, Derk-Jan Dijk, Vladimir Svetnik, Yevgen Tymofyeyev, Shubhankar Ray, James K Walsh, Steve Deacon

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00102167 (A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 37% 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.

NCT00102167 phase3completednot on this map

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia

TypeinterventionalSponsorH. Lundbeck A/SRan2005 to 2005Enrolled663ConditionsInsomniaArmsgaboxadol
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Evaluating the evidence for sex differences: a scoping review of human neuroimaging in psychopharmacology research.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2022
    Article
  9. Article
  10. Sex differences in the circadian regulation of sleep and waking cognition in humans.Proceedings of the National Academy of Sciences of the United States of America · 2016
    Article
  11. 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

7 authors at 4 institutions in 3 countries.

Junshui MaMerck Research Laboratories, Biometrics Research, Rahway, NJ, USA.
Derk-Jan Dijk
Vladimir Svetnik
Yevgen Tymofyeyev
Shubhankar Ray
James K Walsh
Steve Deacon
Merck & Co., Inc., Rahway, NJ, USA (United States) · USLundbeck (Denmark) · DKSt. Luke's Hospital · USUniversity of Surrey · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectiveTo explore the effect of gaboxadol on NREM EEG in transient insomnia using power spectral analysis and evaluate the response between men and women.

methodsThis was a randomized, double-blind, 3-way, parallel-group transient insomnia study in 22 sleep laboratories. After a baseline night (N1), subjects underwent a 4-h phase-advance of their habitual sleep time the following night (N2). Healthy subjects aged 18-64 y were given single-blind placebo on N1 followed by double-blind treatment on N2 (gaboxadol 10 mg [n = 271], 15 mg [n = 274], or placebo [n = 277])

resultsAt baseline, women showed significantly greater values in low frequency activity (< 10 Hz) and in high spindle/low beta frequency activity (14-18 Hz) compared to men. During the phase advance (placebo N2-baseline N1), there was a significant increase in power within the high spindle/low beta frequency range (15-17 Hz) and a significant reduction in beta activity (20-32 Hz), which was greater in women than men. Gaboxadol induced a significant (dose-related) increase in low frequencies (< 8 Hz) and a significant (dose-related) decrease within the alpha/spindle range (11-12 Hz). The effect was dependent upon sex, with a greater magnitude of effect observed in women than men.

conclusionGaboxadol shows a characteristic NREM EEG spectral profile in a model of transient insomnia. Men and women show clear differences in NREM EEG activity at baseline, to gaboxadol treatment and to phase-shifts in habitual sleep/wake times. The exact mechanisms underlying the sex differences remain unclear, but sex is an important variable in studies evaluating sleep and gaboxadol. TRIAL REGISTRY INFORMATION: TRIAL REGISTRY: www.clinicaltrials.gov, study identifier: NCT00102167.

Indexed as

AdolescentAdultCross-Over StudiesDouble-Blind MethodElectroencephalographyFemaleGABA AgonistsHumansIsoxazolesMaleMiddle AgedSex DistributionSleep Initiation and Maintenance DisordersTime FactorsYoung AdultGABA AgonistsgaboxadolIsoxazolesEEG power spectragaboxadolGender differencesslow wave sleeptransient insomnia

Identifiers

PMID22003345
PMCPMC3190849
OpenAlexW2074825849

What OpenQuestion holds

Textmetadata
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.