Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Servo-Ventilation on CO2 Regulation and Heart Rate Variability

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890939
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : May 9, 2019
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
University of Arizona

Brief Summary:

Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a condition where the upper airway partially collapses and closes. This can lead to sleep problems including low oxygen levels, poor sleep, elevated carbon dioxide levels in the blood, and activation of the sympathetic nervous system. Results from having disrupted sleep may be excessive daytime sleepiness along with behavioral, functional, cardiovascular and cognitive dysfunction. Continuous Positive Airway Pressure (CPAP) is the most effective treatment for OSAHS. CPAP stabilizes the airway and prevents instability and collapse. Other forms of positive airway pressure that are approved for the treatment of OSAHS include automatically adjusting CPAP, Bi-level Positive Airway Pressure (BiPAP), and automatically adjusting BiPAP. Automatically adjusting CPAP (Auto CPAP) evaluates the airflow pattern and adjusts pressure to optimize airflow. AutoSV (Auto Servo Ventilation) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea.

In the prior study, the investigators found that the Auto S7 device led to more positive ventilation outcomes. Specifically, there was prolongation of QTc interval (the calculated time from the Q wave to the end of the T wave) and a tendency for greater premature ventricular contractions. The mechanistic basis for this could be attributable to excessive ventilation and related pro-arrhythmic effects of hypocapnia, though the investigators had not performed measures (partial pressure of CO2 (PaCO2) to detect this.

In the current study, the investigators would like to investigate the hypothesis that the S7 device leads to lower PaCO2 levels than other devices, and whether these effects are augmented in individuals with complex sleep apnea in the setting of systolic heart failure.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Mixed Heart Failure Device: BiPAP AutoSV Advanced System One Device: Dreamstation BiPaP AutoSV Device: ResMed S7 VPAP Adapt Device Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will receive three (3) randomized PSG's during which they will receive treatment from the following devices in a randomized manner:

  • FDA released Philips BiPAP AutoSV Advanced System One
  • FDA released Philips Dreamstation BiPAP AutoSV
  • FDA released ResMed S7 VPAP Adapt
Masking: None (Open Label)
Masking Description: There will be no masking involved in this study.
Primary Purpose: Treatment
Official Title: Effect of Servo-Ventilation on CO2 Regulation and Heart Rate Variability
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: BiPAP AutoSV Advanced System One Device: BiPAP AutoSV Advanced System One
A mode of positive airway pressure used to treat sleep apnea. The difference between this device and the other experimental device is in the algorithm of the pressure settings.

Experimental: Dreamstation BiPAP AutoSV Device: Dreamstation BiPaP AutoSV
A mode of positive airway pressure used to treat sleep apnea. The difference between this device and the other experimental device is in the algorithm of the pressure settings.

Active Comparator: ResMed S7 VPAP Adapt device Device: ResMed S7 VPAP Adapt Device
A mode of positive airway pressure used to treat sleep apnea. This device is widely used by physicians to treat sleep apnea and will be the active comparator to the two experimental devices.




Primary Outcome Measures :
  1. Minute Ventilation [ Time Frame: Change from Baseline through Day 4 ]
    Minute Ventilation is the amount of air the subject moves in one minute. It is a product of the ventilatory rate and tidal volume. Scores are reported in liters per volume, and is collected from the ventilation device.

  2. Tidal Volume [ Time Frame: Change from Baseline through Day 4 ]
    Tidal Volume is the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. Scores are reported in ml/kg, and is collected from the ventilation device.

  3. Respiratory Rate [ Time Frame: Change from Baseline through Day 4 ]
    Respiratory Rate is measured by the number of breaths taken per minute. Scores are reported in breaths per minute, and is collected from the ventilation device.

  4. QTc Intervals [ Time Frame: Change from Baseline through Day 4 ]
    QTC intervals are utilized to assess the time it takes for the heart to go from the start of the Q wave to the end of the T wave, and approximates to the time taken from when the cardiac ventricles start to contract when they finish relaxing. Scores are reported in milliseconds, and is collected from the electrocardiogram.

  5. Acid-Base Status [ Time Frame: Change from Baseline through Day 4 ]
    Acid-base status is utilized to determine if subjects have increased/decreased partial carbon dioxide levels (PCO2), or decreased/increased extracellular base excess or actual Bicarbonate levels (HCO3). This is measured through transcutaneous PCO2 monitoring as well as through venipuncture blood collection. Scores are reported in millimoles per liter (mmol/l).

  6. Electrolyte Status [ Time Frame: Change from Baseline through Day 4 ]
    Electrolytes Sodium (Na), Potassium (K), and Chlorine (CI) is collected through venipuncture blood collection. Scores are reported in millimoles per liter (mmol/l).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Ability to provide consent
  • Currently prescribed servo ventilation therapy at home
  • At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 10 of 14 nights)
  • Individuals with complex sleep apnea (obstructive sleep apnea with central apneas) and preserved left-ventricular ejection fraction (LVEF > 45%) and/or heart failure with preserved ejection fraction (HFrEF) who are currently on ASV therapy.
  • Individuals with complex sleep apnea (predominantly obstructive sleep apnea with central apneas) and reduced left-ventricular ejection fraction (LVEF < 45%) and/or heart failure with reduced ejection fraction (HFrEF) who are currently on ASV therapy.

Exclusion Criteria:

  • Participants who are acutely ill, medically complicated or who are medically unstable
  • Participants in whom PAP therapy is otherwise medically contraindicated
  • Participants who are claustrophobic
  • Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) AND moderate to severe predominant central sleep apnea
  • Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg).
  • Participants requiring any kind of oxygen therapy
  • Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle ear within the previous 90 days.

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): NCT03890939


Contacts
Layout table for location contacts
Contact: Chris Morton (520) 626-8457 cjmorton@email.arizona.edu
Contact: Sarah Berryhill smarkows@email.arizona.edu

Sponsors and Collaborators
University of Arizona
Philips Respironics
Investigators
Layout table for investigator information
Principal Investigator: Sairam Parthasarathy, MD University of Arizona
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03890939    
Other Study ID Numbers: ASV0000001
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Arizona:
Sleep Apnea, Mixed
Sleep Apnea Device
BiPap device
Sleep Study
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases