Trial reportSleep & breathing = Schlaf & Atmung2021
Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea.
Trial report in Sleep & breathing = Schlaf & Atmung, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 15 papers, 3 of them syntheses that pooled 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.
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.
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)
Who cites it
15 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Content Comparison of Quality-of-Life Instruments Used in Economic Evaluations of Sleep Disorder Interventions: A Systematic Review.PharmacoEconomics · 2024Pooled it
- Pooled it
- Patient-reported outcomes with hypoglossal nerve stimulation for treatment of obstructive sleep apnea: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023Pooled it
- Trial
- Subjective and objective measures of sleep-related function from the Cardiovascular Endpoints For Obstructive Sleep Apnea with Twelfth Cranial Nerve Stimulation (CARDIOSA-12) trial : Sleep-related functional outcomes in CARDIOSA-12.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026Trial
- Trial
- Effect of tirzepatide treatment on patient-reported outcomes among SURMOUNT-OSA participants with obstructive sleep apnea and obesity.Sleep medicine · 2025Trial
- A minimal clinically important difference for the sleep inertia visual analog scale in idiopathic hypersomnia.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025Trial
- Excess daytime sleepiness, daily functioning and health-related quality of life during the first year after metabolic and bariatric surgery in patients with a known and unknown obstructive sleep apnea status.Sleep & breathing = Schlaf & Atmung · 2026Observational
- Optimizing Surgical Choice in Mild and Moderate OSA: Anterior Palatoplasty vs. Radiofrequency Uvulopalatoplasty.Life (Basel, Switzerland) · 2026Article
- Positional Therapy: A Real Opportunity in the Treatment of Obstructive Sleep Apnea? An Update from the Literature.Life (Basel, Switzerland) · 2025Review
- Feasibility and acceptability of switching from a previous-generation to a new-generation mask for positive airway pressure therapy of sleep apnea using remote care.Sleep medicine: X · 2024Article
- An empirical comparison of sleep-specific versus generic quality of life instruments among Australians with sleep disorders.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024Article
- Most-Cited Patient-Reported Outcome Measures Within Otolaryngology-Revisiting the Minimal Clinically Important Difference: A Review.JAMA otolaryngology-- head & neck surgery · 2023Article
- Racial Differences in Functional and Sleep Outcomes with Positive Airway Pressure Treatment.Diagnostics (Basel, Switzerland) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study estimated thresholds for clinically important responses and minimally important differences for two indicators of improvement for the 10-item version of the functional outcomes of sleep questionnaire (FOSQ-10).
methodsParticipants with excessive daytime sleepiness with narcolepsy or obstructive sleep apnea received 12 weeks of solriamfetol treatment. Participants completed the FOSQ-10 and other patient-reported outcome measures, including the single-item patient global impression of change (PGI-C) assessment. Clinicians completed the single-item clinician global impression of change (CGI-C) for each participant. Data from the two studies were analyzed separately, both without regard to treatment assignment. In total, 690 participants (47% female, mean age 48 years, 77% Caucasian, 91% from North America) were enrolled. Two clinically important changes, defined as a minimally important difference and a clinically important response, were determined using distribution and anchor-based analyses. A receiver operating characteristic analysis was used to determine the optimal FOSQ-10 change threshold.
resultsSpearman correlations between change in FOSQ-10 scores and PGI-C and CGI-C were - 0.57 and - 0.49 for participants with narcolepsy and - 0.42 and - 0.37 for participants with obstructive sleep apnea. Receiver operating characteristic analysis suggested minimally important difference and clinically important response estimates of 1.7 and 2.5 and 1.8 and 2.2 points in narcolepsy and obstructive sleep apnea, respectively.
conclusionsMinimally important difference and clinically important response estimates for the FOSQ-10 for adults with excessive daytime sleepiness in narcolepsy or obstructive sleep apnea will be helpful for interpreting changes over time and defining a clinical responder. CLINICALTRIALS. GOV IDENTIFIERS: NCT02348593 (first submitted January 15, 2015) and NCT02348606 (first submitted January 15, 2015).
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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.