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OpenTrials
Completed

NCT Number: NCT03011294

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Luciano Drager

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bed partners of patients with moderate to severe OSA

Exclusion criteria

  • Bed partners with OSA using specific treatment.

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

Standard treatment for sleep apnea

Nasal strip

Device

Placebo

Primary outcomes

  1. Endothelial function (forearm dilation, FMD - %)

    Time frame: 3 months

Secondary outcomes

  1. Sleep quantity (measured by actigraphy - hours/night)

    Time frame: 3 months

    1 week of wrist actigraphy

  2. Sleep quality (Pittsburgh Questionnaire)

    Time frame: 3 months

  3. Ambulatory blood pressure monitoring (ABPM)

    Time frame: 3 months

  4. Frequency of OSA

    Time frame: Baseline only

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: SLEEP-PARTNERS

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2017
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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