Evidence map›Paper›PMID 31209698›Full record

Trial reportAdvances in therapy2019

Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials.

Michael J Noss, Renee Ciesla, Gilbert Shanga

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 42% 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.

NCT03549117 phase2completednot on this map

Pivotal Subjective Sleep Study of a Nasal Dilator

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2011Enrolled140ConditionsCongestion, NasalArmsBreathe Right Tan (small/medium) nasal strips, Placebo nasal strip
NCT03549130 phase2completednot on this map

Pivotal Subjective Sleep Study of a Nasal Dilator

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2011Enrolled130ConditionsCongestion, NasalArmsBreathe Right Tan (small/medium) nasal strips, Placebo nasal strip
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Michael J NossSynexus (Formerly Radiant Research), Cincinnati, OH, USA. michaelnossmd@gmail.com.
Renee CieslaClinical Development and Medical Affairs, GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.
Gilbert ShangaBiostatistics Research and Development, GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.
GlaxoSmithKline (United States) · USSynexus (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTwo multicenter, double-blind, randomized controlled trials assessed the effect of Breathe Right Nasal Strips (BRNS) on sleep-related quality of life in otherwise healthy subjects with chronic nocturnal nasal congestion who reported trouble sleeping.

methodsSubjects were randomized to BRNS or a placebo strip for approximately 8 h each night for 14 days. Efficacy was assessed in the clinic using the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ).

resultsA total of 140 subjects were randomized in Study 1, and 130 in Study 2. There was no significant difference between BRNS and placebo on either the NRQLQ "Sleep Problems" domain or the "Feel Tired and Unrefreshed" item of the "Symptoms on Waking in the Morning" domain at day 7 or 14. There was, however, a significant change in the least squares mean difference from baseline to days 7 and 14 in both the BRNS and placebo arms for each of these endpoints. BRNS were well tolerated.

conclusionsBRNS did not significantly improve subjective measures of sleep quality and nasal congestion compared with placebo strips in this population of chronic nocturnal congestion sufferers with self-reported sleep impairment, possibly due to a strong placebo effect.

fundingGlaxoSmithKline Consumer Healthcare. CLINICALTRIALS. GOV REGISTRATION NUMBERS: Study 1: NCT03549117; Study 2: NCT03549130.

Indexed as

Quality of LifeAdolescentAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedMouth BreathingNasal ObstructionSleep Wake DisordersSurveys and QuestionnairesTreatment OutcomeYoung AdultQuality of lifeRandomized controlled trialRespiratoryRhinitisSleep

Identifiers

PMID31209698
PMCPMC6822978
OpenAlexW2952824195

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.