Evidence map›Paper›PMID 33993394›Full record

Trial reportSleep & breathing = Schlaf & Atmung2022

Initiation of therapy for obstructive sleep apnea syndrome: a randomized comparison of outcomes of telemetry-supported home-based vs. sleep lab-based therapy initiation.

Ingo Fietze, Sebastian Herberger, Gina Wewer, Holger Woehrle, Katharina Lederer, Aline Lips, Leslee Willes, Thomas Penzel

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Guideline
  2. Virtual consultations for patients with obstructive sleep apnoea: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2022
    Pooled it
  3. Article
  4. Article
  5. Article
  6. Review
  7. [Bidirectional aspects of SARS-CoV-2 and sleep disorders].Somnologie : Schlafforschung und Schlafmedizin = Somnology : sleep research and sleep medicine · 2022
    Review
  8. Review
  9. 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

8 authors at 2 institutions in 2 countries.

Ingo FietzeCenter for Cardiovascular Medicine, Interdisciplinary Center for Sleep Medicine, Charité-Universitätsmedizin Berlin, Luisenstraße 13, 10117, Berlin, Germany. ingo.fietze@charite.de.ORCID 0000-0001-5567-5206
Sebastian HerbergerCenter for Cardiovascular Medicine, Interdisciplinary Center for Sleep Medicine, Charité-Universitätsmedizin Berlin, Luisenstraße 13, 10117, Berlin, Germany.
Gina WewerCenter for Cardiovascular Medicine, Interdisciplinary Center for Sleep Medicine, Charité-Universitätsmedizin Berlin, Luisenstraße 13, 10117, Berlin, Germany.
Holger WoehrleSleep and Ventilation Center Blaubeuren, Lung Center Ulm, Ulm, Germany.
Katharina LedererAdvanced Sleep Research GmbH, Berlin, Germany.
Aline LipsSleep and Ventilation Center Blaubeuren, Lung Center Ulm, Ulm, Germany.
Leslee WillesWilles Consulting Group, San Diego, CA, USA.
Thomas PenzelCenter for Cardiovascular Medicine, Interdisciplinary Center for Sleep Medicine, Charité-Universitätsmedizin Berlin, Luisenstraße 13, 10117, Berlin, Germany.
Charité - Universitätsmedizin Berlin · DESaratov State University · RU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDiagnosis and treatment of obstructive sleep apnea are traditionally performed in sleep laboratories with polysomnography (PSG) and are associated with significant waiting times for patients and high cost. We investigated if initiation of auto-titrating CPAP (APAP) treatment at home in patients with obstructive sleep apnea (OSA) and subsequent telemonitoring by a homecare provider would be non-inferior to in-lab management with diagnostic PSG, subsequent in-lab APAP initiation, and standard follow-up regarding compliance and disease-specific quality of life.

methodsThis randomized, open-label, single-center study was conducted in Germany. Screening occurred between December 2013 and November 2015. Eligible patients with moderate-to-severe OSA documented by polygraphy (PG) were randomized to home management or standard care. All patients were managed by certified sleep physicians. The home management group received APAP therapy at home, followed by telemonitoring. The control group received a diagnostic PSG, followed by therapy initiation in the sleep laboratory. The primary endpoint was therapy compliance, measured as average APAP usage after 6 months.

resultsThe intention-to-treat population (ITT) included 224 patients (110 home therapy, 114 controls); the per-protocol population (PP) included 182 patients with 6-month device usage data (89 home therapy, 93 controls). In the PP analysis, mean APAP usage at 6 months was not different in the home therapy and control groups (4.38 ± 2.04 vs. 4.32 ± 2.28, p = 0.845). The pre-specified non-inferiority margin (NIM) of 0.3 h/day was not achieved (p = 0.130); statistical significance was achieved in a post hoc analysis when NIM was set at 0.5 h/day (p < 0.05). Time to APAP initiation was significantly shorter in the home therapy group (7.6 ± 7.2 vs. 46.1 ± 23.8 days; p < 0.0001).

conclusionUse of a home-based telemonitoring strategy for initiation of APAP in selected patients with OSA managed by sleep physicians is feasible, appears to be non-inferior to standard sleep laboratory procedures, and facilitates faster access to therapy.

Indexed as

TelemetryAdultAgedAged, 80 and overFemaleHome Care ServicesHumansLaboratoriesMaleMiddle AgedSleepSleep Apnea, ObstructiveTreatment OutcomeYoung AdultAdherenceAutomatic positive airway pressureComplianceContinuous positive airway pressureObstructive sleep apnea

Identifiers

PMID33993394
PMCPMC8857114
OpenAlexW3160629480

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.