Evidence map›Paper›PMID 22303998›Full record

Trial reportPacing and clinical electrophysiology : PACE2012

Sleep quality and sleepiness in persons with implantable cardioverter defibrillators: outcome from a clinical randomized longitudinal trial.

Selina Kikkenborg Berg, Melinda Higgins, Carolyn M Reilly, Jonathan J Langberg, Sandra B Dunbar

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

Trial report in Pacing and clinical electrophysiology : PACE, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00146679 (Psychoeducational Intervention for ICD Patients), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT00146679 nacompletednot on this map

Psychoeducational Intervention for ICD Patients (PEACE)

TypeinterventionalSponsorEmory UniversityRan2001 to 2006Enrolled246ConditionsHeart Failure, Ventricular ArrhythmiasArmsPsychoeducational Telephone counseling (TC), Psychoeducational Intervention by Group (SG), Usual Care
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 26 citations in OpenAlex.

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  8. Ayurvedic doshas as predictors of sleep quality.Medical science monitor : international medical journal of experimental and clinical research · 2015
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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

5 authors at 2 institutions in 2 countries.

Selina Kikkenborg BergCopenhagen University Hospital, Rigshospitalet, The Heart Center, Copenhagen, Denmark. selina@rh.dk
Melinda Higgins
Carolyn M Reilly
Jonathan J Langberg
Sandra B Dunbar
Emory University · USCopenhagen University Hospital · DK

Funding

PSYCHOEDUCATIONAL INTERVENTION FOR ICD PATIENTSR01NR005187 · NINR · EMORY UNIVERSITY · PI DUNBAR, SANDRA B. · 2000 to 2003
$2.0M
NINR NIH HHS R01 NR005187PHS HHS R01 5187
6 · The paper itself

Abstract

backgroundPatients receiving an implantable cardioverter defibrillator (ICD) report various types and degree of sleep disruptions, but little is known regarding their characteristics, duration, and associated factors. The purposes of this study were: (1) to describe the effect of a psychoeducational intervention on sleep quality and daytime sleepiness, (2) to describe patterns of sleep over time, and (3) to identify predictors of poor sleep in an ICD population.

methodsA randomized longitudinal intervention trial was designed to test the effects of a psychoeducational intervention, which included a sleep education and counseling session in patients receiving their initial ICD. Patients (n=236; 75% men; mean age 58.4 [±11.2] from the PsychoEducationAl Intervention for ICD PatiEnts (PEACE) trial comprised the study population. Variables related to sleep were measured by the Pittsburgh Sleep Quality Inventory (PSQI) and Epworth Sleepiness Scale (ESS).

resultsNo psychoeducational intervention effects on sleep outcomes were observed. However, 67.2% of the patients reported poor sleep quality at baseline, and 56.8% had low sleep quality at 6 months based on PSQI scores>5; one-third (32.6%) were excessively sleepy based on ESS scores≥10 at 6 months. Anxiety, depression, physical function, pain intensity, and pain severity were all highly correlated to each other across time. Female gender was a significant covariate for the PSQI. New York Heart Association (NYHA) class was a significant covariate for sleepiness (Epworth).

conclusionsLow sleep quality and daytime sleepiness are found at time of insertion and over time in patients with ICD. Female gender, higher NYHA class, as well as two latent factors encompassing increased anxiety, depressive symptoms, and decreased physical function and increased pain, were significant predictors of poor sleep quality and sleepiness over time. These data help identify those at higher risk for sleep problems after ICD.

Indexed as

SleepAgedAnxietyDefibrillators, ImplantableDepressionDisorders of Excessive SomnolenceFemaleHumansLongitudinal StudiesMaleMiddle AgedPainRiskSeverity of Illness IndexSex Factors

Identifiers

PMID22303998
PMCPMC3681948
OpenAlexW2079081797

What OpenQuestion holds

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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.