Trial reportSleep & breathing = Schlaf & Atmung2021
Transvenous phrenic nerve stimulation improves central sleep apnea, sleep quality, and quality of life regardless of prior positive airway pressure treatment.
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 trial NCT01816776 (A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea), which is not on this map. Cited by 4 papers, 1 of them a synthesis 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 Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Pharmacological treatment for central sleep apnoea in adults.The Cochrane database of systematic reviews · 2023Pooled it
- Bridge over troubled water: A novel application of an occlusion balloon in phrenic nerve stimulator implantation.HeartRhythm case reports · 2026Article
- Revisiting Transvenous Phrenic Nerve Stimulation in Central Sleep Apnoea and Heart Failure: Emerging Innovations in Clinical Trials Analysis.Cardiac failure review · 2025Review
- Treating central sleep apnoea in heart failure: progressing one step at a time.European respiratory review : an official journal of the European Respiratory Society · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 1 country.
Funding
Abstract
STUDY
objectivePositive airway pressure (PAP) therapy for central sleep apnea (CSA) is often poorly tolerated, ineffective, or contraindicated. Transvenous phrenic nerve stimulation (TPNS) offers an alternative, although its impact on previously PAP-treated patients with CSA has not been examined.
methodsTPNS responses among PAP-naïve and prior PAP-treated patients from the remedē
resultsPatients had moderate-severe CSA at baseline, which was of greater severity and more symptomatic in the PAP-treated vs. PAP-naïve group (median AHI 52/h vs. 38, central apnea index (CAI) 32/h vs. 18, Epworth Sleepiness Scale 13 vs. 10, fatigue severity scale 5.2 vs. 4.5). Twelve months of TPNS decreased AHI to <20/h and CAI to ≤2/h. Both groups showed reductions in daytime sleepiness and fatigue, improved well-being by patient global assessment, and high therapeutic acceptance with 98% and 94% of PAP-treated and PAP-naïve patients indicating they would undergo the implant again. Stimulation produced discomfort in approximately one-third of patients, yet <5% of prior PAP-treated participants discontinued therapy.
conclusionPolysomnographic and clinical responses to TPNS were comparable in PAP-naïve and prior PAP-treated CSA patients. TPNS is a viable therapy across a broad spectrum of CSA patients.
trial registrationClinicalTrials.gov Identifier NCT01816776; March 22, 2013.
Indexed as
Identifiers
What OpenQuestion holds
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.