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Clinical Trials/NCT03011294
NCT03011294
Completed
Phase 4

Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea: a Randomized Study

University of Sao Paulo1 site in 1 country60 target enrollmentDecember 1, 2018

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Sleep Apnea Syndromes
Sponsor
University of Sao Paulo
Enrollment
60
Locations
1
Primary Endpoint
Endothelial function (forearm dilation, FMD - %)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact not limited to the patients but also to the partner that sleep in the same bed. Is it reasonable to speculate that the partner suffer sleep deprivation, increased level of irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA patient. Although previous data reported impaired sleep quality in partners of patients with OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the improvements in the subjective and objective sleep. Thus, the main objectives of this randomized controlled study are: to evaluate the impact of three months of randomization (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of patients with moderate to severe OSA.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
June 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luciano F Drager, MD, PhD

Associate Professor of Medicine

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Bed partners of patients with moderate to severe OSA

Exclusion Criteria

  • Bed partners with OSA using specific treatment.

Outcomes

Primary Outcomes

Endothelial function (forearm dilation, FMD - %)

Time Frame: 3 months

Secondary Outcomes

  • Frequency of OSA(Baseline only)
  • Ambulatory blood pressure monitoring (ABPM)(3 months)
  • Sleep quantity (measured by actigraphy - hours/night)(3 months)
  • Sleep quality (Pittsburgh Questionnaire)(3 months)

Study Sites (1)

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