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

NCT03890939 | Unknown Phase 4 FDA Device

• 1 other identifier: ASV0000001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Apnea, Mixed; Heart Failure

Keywords

Sleep Apnea, Mixed; Sleep Apnea Device; BiPap device; Sleep Study

Outcome Measures

Primary Outcomes (6)

• Minute Ventilation

  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.

  Change from Baseline through Day 4

• Tidal Volume

  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.

  Change from Baseline through Day 4

• Respiratory Rate

  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.

  Change from Baseline through Day 4

• QTc Intervals

  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.

  Change from Baseline through Day 4

• Acid-Base Status

  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).

  Change from Baseline through Day 4

• Electrolyte Status

  Electrolytes Sodium (Na), Potassium (K), and Chlorine (CI) is collected through venipuncture blood collection. Scores are reported in millimoles per liter (mmol/l).

  Change from Baseline through Day 4

Study Arms (3)

BiPAP AutoSV Advanced System One

EXPERIMENTAL

Device: BiPAP AutoSV Advanced System One

Dreamstation BiPAP AutoSV

EXPERIMENTAL

Device: Dreamstation BiPaP AutoSV

ResMed S7 VPAP Adapt device

ACTIVE COMPARATOR

Device: ResMed S7 VPAP Adapt Device

Interventions

BiPAP AutoSV Advanced System One DEVICE

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.

BiPAP AutoSV Advanced System One

Dreamstation BiPaP AutoSV DEVICE

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.

Dreamstation BiPAP AutoSV

ResMed S7 VPAP Adapt Device 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.

ResMed S7 VPAP Adapt device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• Philips Respironics: collaborator

MeSH Terms

Conditions

Sleep Apnea Syndromes; Heart Failure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Sairam Parthasarathy, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Morton

CONTACT

(520) 626-8457; cjmorton@email.arizona.edu

Sarah Berryhill

CONTACT

smarkows@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There will be no masking involved in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 26, 2019
• Study Start: July 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share