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Trial record 8 of 398 for:    Recruiting, Not yet recruiting, Available Studies | "Sleep Apnea Syndromes"

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

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ClinicalTrials.gov Identifier: NCT03011294
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Information provided by (Responsible Party):
Luciano F Drager, University of Sao Paulo

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 and a recent diagnosis of Metabolic Syndrome (MetS) according to the ATP III criteria derived from an ongoing randomized study conducted in our Institution.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: Continuous positive airway pressure (CPAP) Device: Nasal strip Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea: a Randomized Study
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: CPAP (in the partner)
Positive airway pressure for treating OSA in the bed partner.
Device: Continuous positive airway pressure (CPAP)
Placebo Comparator: Nasal strips (in the partner)
Use od nasal dilator as a placebo for treating OSA in the bed partner.
Device: Nasal strip

Primary Outcome Measures :
  1. Endothelial function (forearm dilation, FMD - %) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Bed partners of patients with moderate to severe OSA that are going to participate in an ongoing randomized study

Exclusion Criteria:

  • Bed partners with OSA using specific treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011294

Contact: Luciano F. Drager, MD, PhD 5511-26615084 luciano.drager@incor.usp.br

Luciano Drager Recruiting
Sao Paulo, Brazil
Contact: Luciano F Drager, MD, PhD       luciano.drager@incor.usp.br   
Sponsors and Collaborators
University of Sao Paulo

Responsible Party: Luciano F Drager, Associate Professor of Medicine, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03011294     History of Changes
Other Study ID Numbers: SDC 4165.14.145
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases