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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Device: Continuous positive airway pressure (CPAP)
* Device: Nasal strip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bed partners of patients with moderate to severe OSA Exclusion Criteria: Bed partners with OSA using specific treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP (in the partner)<br>Positive airway pressure for treating OSA in the bed partner. | Device: Continuous positive airway pressure (CPAP)<br> <br> |
| Placebo Comparator: Nasal strips (in the partner)<br>Nasal dilator as a placebo for treating OSA in the bed partner. | Device: Nasal strip<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function (forearm dilation, FMD - %) |  | 3 months | 

Secondary Outcome Measures

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