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Obstructive Sleep Apnea and Arterial Stiffness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02329470
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Karl A Franklin, Umeå University

Brief Summary:
A randomized, controlled study in parallel design recruiting 100 patients, 50 in each group. The patients have had CPAP (Continuous Positive Airway Pressure) treatment between 2 months to 2 years. The patients are investigated, then half of them (50 patients) are randomized to withdrawal of CPAP treatment during 3-5 nights followed by second investigation. 50 patients (control group) continue with CPAP but are investigated similarly than CPAP withdrawal group after 3-5 nights. The aim of the study is to investigate the effects of obstructive sleep apnea to arterial stiffness and 24 hour blood pressure (primary outcome) and whether there is increase in insulin resistance, cathecol amines, if systemic inflammation occurs after short-term CPAP withdrawal, and what is the impact of age, gender and oxygen saturation on arterial stiffness (secondary outcomes).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Cardiovascular Disease Procedure: Withdrawal of CPAP treatment Not Applicable

Detailed Description:

Inclusion criteria: 100 patients with successful CPAP treatment of obstructive sleep apnea.

Exclusion criteria: Dementia, heart infarction within 3 months Randomization: 50 patients are randomised to sleep 5 days without CPAP and the other 50 continue with CPAP as usual Method: .Sleep apnea investigation using Embletta, ResMed while patients are treated with CPAP during one night. Urinary samplings during the same night. Questionnaire. They are investigated next day for arterial stiffness using Vicord (Skidmore Medical UK) with pulse wave analysis using sphygmomanometer (Omron Japan). Blood samples are taken.

The same investigations are done 5 days later where half of the patients have been on CPAP treatment and half of the has slept without.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cardiovascular Effects of CPAP Treatment for Obstructive Sleep Apnea
Study Start Date : March 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: No device, n=50
Withdrawal of device, CPAP, of obstructive sleep apnea treatment during 5 nights
Procedure: Withdrawal of CPAP treatment
Withdrawal of CPAP treatment

No Intervention: Device, CPAP, n=50
Continues with device, CPAP, treatment for obstructive sleep apnea during the study frame



Primary Outcome Measures :
  1. Arterial stiffness measured with Vicore and pulse wave analysis [ Time Frame: 5 days ]
    Effect of CPAP treatment on arterial stiffness measured with Vicore and pulse wave analysis

  2. 24 hour blood pressure measurements [ Time Frame: 5 days ]
    Effect on systolic and diastolic blood pressure


Secondary Outcome Measures :
  1. Insulin resistance measured with s-glucose and plasma insulin [ Time Frame: 5 days ]
    Does short-term CPAP withdrawal increase insulin resistance measured with s-glucose and plasma insulin

  2. Measurements of urinary catechol amines [ Time Frame: 5 days ]
    measurements of urinary catechol amines during one day

  3. Occurence of systemic inflammation during short-term CPAP withdrawal as measured by CRP, IL-6, TNF-alpha, Isoprostan [ Time Frame: 5 days ]
    measurements of CRP, IL-6, TNF-alpha, Isoprostan

  4. Impact of oxygen saturation on arterial stiffness during short-term CPAP withdrawal [ Time Frame: 5 days ]
    Does oxygen saturation has an impact on arterial stiffness during short-term CPAP withdrawal

  5. daytime sleepiness and arterial stiffness as measured by the Epworth sleepiness scale and the Karolinska sleepiness scale [ Time Frame: 5 days ]
    Epworth sleepiness scale, Karolinska sleepiness scale,

  6. Apnea-hypopnea index [ Time Frame: 5 days ]
    Effect on apnea and hypopnea index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older,
  • given the written consent to participate in the study,
  • 2 months to 2 years prior treatment with CPAP,
  • moderate sleep apnea with AHI (Apnea Hypopnea Index) >15 (more than 15 events per hour)

Exclusion Criteria:

  • AHI > 10 with CPAP treatment,
  • heart infarction within 3 months prior to study participation,
  • severe dementia,
  • determined by study personal having psychological or physical hinder to participate in the study

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): NCT02329470


Locations
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Sweden
Dept of Respiratory Medicine
Umeå, Sweden, 901 85
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Karl A Franklin, Ass pof umea University
Study Director: Carin Sahlin, PhD Umea University
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Responsible Party: Karl A Franklin, Ass Prof, Umeå University
ClinicalTrials.gov Identifier: NCT02329470    
Other Study ID Numbers: Dnr: 2010-329-31M
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases