Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea (SLEEP-PARTNERS)

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Sleep Apnea Syndromes

Treatments: Device: Continuous positive airway pressure (CPAP); Device: Nasal strip

Study type: Interventional

Funder types: Other

Identifiers

NCT03011294

SDC 4165.14.145

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Bed partners of patients with moderate to severe OSA

Exclusion criteria

• Bed partners with OSA using specific treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

CPAP (in the partner)

Active Comparator group

Description:

Positive airway pressure for treating OSA in the bed partner.

Treatment:

Device: Continuous positive airway pressure (CPAP)

Nasal strips (in the partner)

Placebo Comparator group

Description:

Nasal dilator as a placebo for treating OSA in the bed partner.

Treatment:

Device: Nasal strip