The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial

Cichelero, Fábio Tremea; Martinez, Denis; Fuchs, Sandra Costa; Gus, Miguel; Moreira, Leila Beltrami; Fuchs, Flávio Danni

doi:10.1186/1745-6215-15-1

Cited by 301Obstructive Sleep Apnea ResearchBlood Pressure and Hypertension StudiesSleep and related disorders

The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial

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Cichelero, Fábio Tremea, Martinez, Denis, Fuchs, Sandra Costa, Gus, Miguel, Moreira, Leila Beltrami, Fuchs, Flávio Danni·2014·Trials

DOI 10.1186/1745-6215-15-1PMC PMC3892032

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Abstract

Background: Obstructive sleep apnea (OSA) and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. Several drugs are used to control hypertension, but the only consistently effective treatment of OSA is continuous positive airway pressure. The identification of a drug capable of improving OSA and hypertension simultaneously would provide a novel approach in the treatment of both diseases. Methods/Design: This is a randomized double-blind clinical trial, comparing the use of chlorthalidone with amiloride versus amlodipine as a first drug option in patients older than 40 years of age with stage I hypertension (140 to 159/90 to 99 mmHg) and moderate OSA (15 to 30 apneas/hour of sleep). The primary outcomes are the variation of the number of apneas per hour and blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes are adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein levels. The follow-up will last 8 weeks. There will be 29 participants per group. The project has been approved by the ethics committee of our institution. Discussion: The role of fluid retention in OSA has been known for several decades. The use of diuretics are well established in treating hypertension but have never been appropriately tested for sleep apnea. As well as testing the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and their treatment. Trial registration: ClinicalTrials.gov: NCT01896661

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This sample size was consistent with sample sizes of 24-35 participants conventionally recommended for pilot and feasibility studies.
“This sample size was consistent with sample sizes of 24–35 participants conventionally recommended for pilot and feasibility studies.7678”
From Acceptance and commitment therapy for mild traumatic brain injury (ACTion-mTBI): a quasiexperimental feasibility study (2025) · cites this paper as [76]
The Methods/design > Sample size calculation section calculates 26 patients per group for this randomized trial, or 58 total after allowing for losses. It does not discuss pilot or feasibility studies or recommend a conventional sample-size range of 24–35 participants; searches for those terms found no supporting passage. (LLM, conf=0.76)
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Self-citation
Effects of Antihypertensive Treatment on Left and Right Ventricular Global Longitudinal Strain and Diastolic Parameters in Patients with Hypertension and Obstructive Sleep Apnea: Randomized Clinical Trial of Chlorthalidone plus Amiloride vs. Amlodipine
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Authors: Cichelero, F. T., Martinez, D., Fuchs, S. C., Gus, M., Moreira, L. B., & Fuchs, F. D.
Affiliations: Universidade Federal do Rio Grande do Sul (BR)
Hospital de Clínicas de Porto Alegre (BR)
Corresponding author: Fuchs, Flávio Danni
ORCID: Cichelero, Fábio Tremea
Moreira, Leila Beltrami
Fuchs, Flávio Danni
Venue: Trials
Publisher: Springer Science and Business Media LLC
Published: 2014-01-02
Volume: 15
Issue: 1
Pages: 1-1
ISSN: 1745-6215 (ISSN-L)
DOI: 10.1186/1745-6215-15-1
PMC: PMC3892032
OpenAlex: W2168495171
Cited by: 301
References: 34
Citations by year: 2026: 1 · 2025: 13 · 2024: 11 · 2023: 7 · 2022: 17 · 2021: 44 · 2020: 31 · 2019: 31 · 2018: 32 · 2017: 57 · 2016: 35 · 2015: 13 · 2014: 8 · 2013: 1
FWCI: 25.11
Type: journal article
Language: en
Open access: gold
doi.org
Licence: cc-by
Locations: Trials (publishedVersion, cc-by)
Europe PMC (PubMed Central) (publishedVersion, cc-by)
PubMed Central (publishedVersion, cc-by)
PubMed (publishedVersion)
Americanae (AECID Library) (publishedVersion, other-oa)
Lume (Universidade Federal do Rio Grande do Sul) (submittedVersion, other-oa)
LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc-sa)
Funders: Hospital de Clínicas de Porto Alegre
Fundação Instituto de Pesquisas Econômicas
Topics: Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
Social Sciences › Psychology › Experimental and Cognitive Psychology › Sleep and related disorders
Keywords: obstructive sleep apnea, hypertension, antihypertensive drugs, chlorthalidone, amiloride, amlodipine, diuretics, fluid retention, apnea-hypopnea index, ambulatory blood pressure monitoring, C-reactive protein, cardiovascular risk factors
MeSH terms: Adult, Antihypertensive Agents, Blood Pressure, Calcium Channel Blockers, Chlorthalidone, Clinical Protocols, Diuretics, Double-Blind Method, Drug Therapy, Combination, Humans, Hypertension, Research Design, Sleep, Sleep Apnea Syndromes, Time Factors, Treatment Outcome, Polysomnography, Amlodipine, Blood Pressure Monitoring, Ambulatory

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The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial

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