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

Primary Purpose

Sleep Apnea Syndromes

Status
Active
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP)
Nasal strip
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Bed partners of patients with moderate to severe OSA

Exclusion Criteria:

  • Bed partners with OSA using specific treatment.

Sites / Locations

  • Luciano Drager

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CPAP (in the partner)

Nasal strips (in the partner)

Arm Description

Positive airway pressure for treating OSA in the bed partner.

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

Outcomes

Primary Outcome Measures

Endothelial function (forearm dilation, FMD - %)

Secondary Outcome Measures

Sleep quantity (measured by actigraphy - hours/night)
1 week of wrist actigraphy
Sleep quality (Pittsburgh Questionnaire)
Ambulatory blood pressure monitoring (ABPM)
Frequency of OSA

Full Information

First Posted
December 27, 2016
Last Updated
April 27, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03011294
Brief Title
Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea
Acronym
SLEEP-PARTNERS
Official Title
Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea: a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2016 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP (in the partner)
Arm Type
Active Comparator
Arm Description
Positive airway pressure for treating OSA in the bed partner.
Arm Title
Nasal strips (in the partner)
Arm Type
Placebo Comparator
Arm Description
Nasal dilator as a placebo for treating OSA in the bed partner.
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Intervention Type
Device
Intervention Name(s)
Nasal strip
Primary Outcome Measure Information:
Title
Endothelial function (forearm dilation, FMD - %)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sleep quantity (measured by actigraphy - hours/night)
Description
1 week of wrist actigraphy
Time Frame
3 months
Title
Sleep quality (Pittsburgh Questionnaire)
Time Frame
3 months
Title
Ambulatory blood pressure monitoring (ABPM)
Time Frame
3 months
Title
Frequency of OSA
Time Frame
Baseline only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Bed partners of patients with moderate to severe OSA Exclusion Criteria: Bed partners with OSA using specific treatment.
Facility Information:
Facility Name
Luciano Drager
City
Sao Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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