Evidence map›Paper›PMID 26407963›Full record

Trial reportSleep & breathing = Schlaf & Atmung2016

Tiotropium Respimat Soft Mist Inhaler versus HandiHaler to improve sleeping oxygen saturation and sleep quality in COPD.

Izolde Bouloukaki, Nikolaos Tzanakis, Charalampos Mermigkis, Katerina Giannadaki, Violeta Moniaki, Eleni Mauroudi, Stylianos Michelakis, Sophia E Schiza

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07311499 (A Study on Improving Sleep Quality in COPD Patients Through Inhalation Management Education by Nurses Using Video Conferencing Tools.), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 23% 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.

NCT07311499 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Study on Improving Sleep Quality in COPD Patients Through Inhalation Management Education by Nurses Using Video Conferencing Tools.

TypeinterventionalSponsorKumamoto UniversityRan2026 to 2029Enrolled60ConditionsChronic Obstructive Lung DiseaseArmsinhalation management education
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Total Sleep Time in the Taiwan Obstructive Lung Disease Cohort.International journal of environmental research and public health · 2021
    Observational
  3. Article
  4. Article
  5. Tiotropium formulations and safety: a network meta-analysis.Therapeutic advances in drug safety · 2017
    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 1 institution in 1 country.

Izolde BouloukakiSleep Disorders Center, Department of Thoracic Medicine, University of Crete, 71110, Heraklion, Crete, Greece. izolthi@gmail.com.
Nikolaos TzanakisSleep Disorders Center, Department of Thoracic Medicine, University of Crete, 71110, Heraklion, Crete, Greece.
Charalampos MermigkisSleep Disorders Center, Department of Thoracic Medicine, University of Crete, 71110, Heraklion, Crete, Greece.
Katerina GiannadakiSleep Disorders Center, Department of Thoracic Medicine, University of Crete, 71110, Heraklion, Crete, Greece.
Violeta MoniakiSleep Disorders Center, Department of Thoracic Medicine, University of Crete, 71110, Heraklion, Crete, Greece.
Eleni MauroudiSleep Disorders Center, Department of Thoracic Medicine, University of Crete, 71110, Heraklion, Crete, Greece.
Stylianos MichelakisSleep Disorders Center, Department of Thoracic Medicine, University of Crete, 71110, Heraklion, Crete, Greece.
Sophia E SchizaSleep Disorders Center, Department of Thoracic Medicine, University of Crete, 71110, Heraklion, Crete, Greece.
University of Crete · GR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePatients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. There is a shortage of data to support the efficacy of long-acting inhaled anticholinergic agents in improving these adverse effects, which are known to have a negative impact on clinical outcomes. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD.

methodsIn a randomized, open-label, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension >60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality. Overnight polysomnography and pulmonary function testing were performed at baseline and after 6 months' treatment.

resultsA total of 188 patients completed the trial. Both groups showed significant improvement in minimum sleep SaO2 and time of sleep spent with SaO2 below 90 (TST90) compared to baseline. The patients using the Respimat had significantly better TST90 than did those using the HandiHaler. Sleep disturbance was highly variable in these patients, but the sleep stage durations were significantly better in the Respimat group.

conclusionsSleeping SaO2 can be improved by tiotropium delivered using either the HandiHaler device or the Respimat Soft Mist Inhaler. However, the patients who used the Respimat device had significantly better TST90 and sleep architecture parameters.

Indexed as

Nasal SpraysNebulizers and VaporizersAdultAgedFemaleHumansLung Volume MeasurementsMaleMiddle AgedOxygenPolysomnographyPulmonary Disease, Chronic ObstructiveSleepTiotropium BromideNasal SpraysOxygenTiotropium BromideAnticholinergic therapyInhaler deviceNocturnal desaturationsSleep architecture

Identifiers

PMID26407963
OpenAlexW1800365056

What OpenQuestion holds

Textmetadata
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.