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NCT03011294 Clinical Trial

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

Sleep Apnea Syndromes Clinical Trial

— SLEEP-PARTNERS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03011294
Other study ID # SDC 4165.14.145
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 1, 2018
Est. completion date June 1, 2024

Study information
Verified date June 2024
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 1, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Bed partners of patients with moderate to severe OSA Exclusion Criteria: - Bed partners with OSA using specific treatment.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Continuous positive airway pressure (CPAP)
Standard treatment for sleep apnea
• Nasal strip
Placebo

Locations
Country Name City State
Brazil Luciano Drager Sao Paulo

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endothelial function (forearm dilation, FMD - %) 3 months
Secondary Sleep quantity (measured by actigraphy - hours/night) 1 week of wrist actigraphy 3 months
Secondary Sleep quality (Pittsburgh Questionnaire) 3 months
Secondary Ambulatory blood pressure monitoring (ABPM) 3 months
Secondary Frequency of OSA Baseline only
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