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OpenTrials
Completed

NCT Number: NCT02270658

Morbidity in Patients With Hypertension and Obstructive Sleep Apnea

MORPHEOS is a multicenter, randomized, unblinded study, for patients diagnosed with uncontrolled hypertension and at least one antihypertensive medication. Those patients with significant sleep apnea wil be randomized to CPAP or nasal strips for 6 months.

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Key information

Conditions

Hypertension Apnea Cardiovascular Diseases Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pronto Socorro Cardiológico de Pernambuco (PROCAPE), Recife, Pernambuco, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
  • Current treatment with at least 1 antihypertensive drug

Exclusion criteria

  • Age <18 and >65 years
  • BMI ≥ 40 kg/m2
  • Heart failure, EF < 45%, acute myocardial infarction, stroke, significant valvular dysfunction
  • Chronic renal failure (serum creatinine > 2 mg/dL)
  • Use of cocaine, amphetamines, alcohol, illicit drugs
  • Use of sympathomimetics (decongestants, appetite suppressants)
  • Use of oral contraceptives and chronic use of NSAIDs
  • Pregnancy
  • Secondary causes of hypertension (other than sleep apnea)

Treatment and study plan

CPAP

Device

Other names: Continuous positive airway pressure

Primary outcomes

  1. Impact of OSA treatment with CPAP on office, 24-hour, and central blood pressure (co-primary endpoints).

    Time frame: 6 months

Secondary outcomes

  1. Impact of OSA treatment with CPAP on target-organ damage

    Time frame: 6 months

  2. Impact of OSA treatment with CPAP on vascular parameters (to be published as a sub-study)

    Time frame: 6 months

    Pulse wave velocity and carotid intima-media thickness

  3. Impact of OSA treatment with CPAP on hypertensive retinopathy and optic nerve damage (to be published as a sub-study)

    Time frame: 6 months

  4. Validation of portable sleep monitoring to diagnose OSA (to be published as a sub-study)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Financiadora de Estudos e Projetos

Registry information

Acronym: MORPHEOS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 21, 2014
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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