MedTrace Logo

Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea

NCT03011294 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-10

No results posted yet for this study

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.

Conditions

  • Sleep Apnea Syndromes

Interventions

DEVICE

Continuous positive airway pressure (CPAP)

Standard treatment for sleep apnea

DEVICE

Nasal strip

Placebo

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2024-04-30
Completion
2024-06-01

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011294 on ClinicalTrials.gov