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

NCT ID: NCT03011294

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2024-06-01

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.

Conditions

Sleep Apnea Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP (in the partner)

Positive airway pressure for treating OSA in the bed partner.

Group Type: ACTIVE_COMPARATOR

Continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

Standard treatment for sleep apnea

Nasal strips (in the partner)

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

Group Type: PLACEBO_COMPARATOR

Nasal strip

Intervention Type: DEVICE

Placebo

Interventions

Continuous positive airway pressure (CPAP)

Standard treatment for sleep apnea

Intervention Type: DEVICE

Nasal strip

Placebo

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Bed partners of patients with moderate to severe OSA

Exclusion Criteria

• Bed partners with OSA using specific treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Luciano F Drager, MD, PhD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Luciano Drager

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

SDC 4165.14.145

Identifier Type: -

Identifier Source: org_study_id