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

Phase 4

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: Nasal strip; Device: Continuous positive airway pressure (CPAP)

• Registration Number: NCT03011294
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Study Start: 2018-12-01
• Primary Completion: 2024-04-30
• Status Verified: 2024-06
• Study Completion: 2024-06-01
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Bed partners of patients with moderate to severe OSA

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Exclusion Criteria

• Bed partners with OSA using specific treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal strips (in the partner)	Nasal strip	Nasal dilator as a placebo for treating OSA in the bed partner.
CPAP (in the partner)	Continuous positive airway pressure (CPAP)	Positive airway pressure for treating OSA in the bed partner.

Primary Outcome Measures

Name	Time	Method
Endothelial function (forearm dilation, FMD - %)	3 months

Secondary Outcome Measures

Name	Time	Method
Frequency of OSA	Baseline only
Ambulatory blood pressure monitoring (ABPM)	3 months
Sleep quantity (measured by actigraphy - hours/night)	3 months	1 week of wrist actigraphy
Sleep quality (Pittsburgh Questionnaire)	3 months

Trial Locations

Locations (1)

Luciano Drager; 🇧🇷 Sao Paulo, Brazil