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Minute Ventilation Adaptive Servo-Ventilation plus SOC for Obstructive Sleep Apnea (ASLEEP PK Trial)

N/A
Waitlist Available
Led By Nancy J Gardetto, Ph.D.
Research Sponsored by Veterans Medical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days post-discharge
Awards & highlights

ASLEEP PK Trial Summary

The primary hypothesis of this study is: the use of minute ventilation-adaptive servo-ventilation (MV-ASV) during hospitalization will mitigate deterioration in renal function and prevent kidney injury in patients admitted with acute heart failure (AHF) compared to those receiving usual care. We will validate and extend our pilot study by taking a deeper dive into the effects of ASV on diuretic dose, urine output and new and exciting biomarkers of renal function and kidney injury. If our hypothesis proves correct, it strongly suggests that ASV lessens injury to the kidney and could lead to a new paradigm for the treatment of AHF. When use of high dose of diuretics are anticipated or in whom chronic kidney disease (CKD) or acute kidney injury (AKI) is present on arrival to the Emergency Department, use of MV-ASV might decrease the amount of diuretics needed, allow for continued use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases in effective glomerular filtration. Since kidney injury is a major factor in those patients with early 30-day readmission following discharge, this therapy could become quite popular.

Eligible Conditions
  • Obstructive Sleep Apnea
  • Heart Failure

ASLEEP PK Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days post-discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days post-discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in Renal Biomarkers
Disposition and post-discharge composite events
Other markers of renal function
+1 more

ASLEEP PK Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Minute Ventilation Adaptive Servo-Ventilation plus SOCExperimental Treatment1 Intervention
Patients in this arm will be instructed to use the adaptive servo-ventilation (ASV) device for up to five days of inpatient stay while in the hospital. Patients are encouraged to use the device during any and all hours of sleep, and as needed during waking hours. Apart from this treatment, no other interventions will be administered, and the patient's standard of care will not otherwise be altered for the purposes of the study.Two 6-mL tubes of blood will be drawn once daily for up to 5 days, and daily questionnaires will be administered regarding sleep and health quality.
Group II: Standard of Care (SOC)Active Control1 Intervention
Patients in this arm will not have their standard of care as dictated by their provider altered in any way. Two 6-mL tubes of blood will be drawn once daily for up to 5 days, and daily questionnaires will be administered regarding sleep and health quality.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adaptive Servo-Ventilation
2015
N/A
~240

Find a Location

Who is running the clinical trial?

Veterans Medical Research FoundationLead Sponsor
43 Previous Clinical Trials
4,912 Total Patients Enrolled
ResMed FoundationOTHER
14 Previous Clinical Trials
1,613 Total Patients Enrolled
Nancy J Gardetto, Ph.D.Principal InvestigatorVeterans Affairs San Diego Healthcare System

Frequently Asked Questions

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~2 spots leftby Apr 2025