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

NCT03011294 | Completed Phase 4

• 1 other identifier: SDC 4165.14.145
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Endothelial function (forearm dilation, FMD - %)

  3 months

Secondary Outcomes (4)

• Sleep quantity (measured by actigraphy - hours/night)

  3 months

• Sleep quality (Pittsburgh Questionnaire)

  3 months

• Ambulatory blood pressure monitoring (ABPM)

  3 months

• Frequency of OSA

  Baseline only

Study Arms (2)

CPAP (in the partner)

ACTIVE COMPARATOR

Positive airway pressure for treating OSA in the bed partner.

Device: Continuous positive airway pressure (CPAP)

Nasal strips (in the partner)

PLACEBO COMPARATOR

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

Device: Nasal strip

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Standard treatment for sleep apnea

CPAP (in the partner)

Nasal strip DEVICE

Placebo

Nasal strips (in the partner)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bed partners of patients with moderate to severe OSA

You may not qualify if:

• Bed partners with OSA using specific treatment.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Luciano Drager

São Paulo, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: January 5, 2017
• Study Start: December 1, 2018
• Primary Completion: April 30, 2024
• Study Completion: June 1, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)