Back to resultsNon-Inferiority Trial of Acute HFT Versus nCPAP
Primary Purpose
Mild-Moderate Obstructive Sleep Disordered Breathing
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-Flow Therapy
Continuous Positive Airway Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Mild-Moderate Obstructive Sleep Disordered Breathing focused on measuring OSA, Obstructive Sleep Apnea, High Flow Therapy, CPAP, HFT, Continuous Positive Airway Pressure, Mild OSA, Moderate OSA
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- Previous diagnosis of primarily obstructive mild-moderate Sleep Disordered Breathing during in-laboratory polysomnography
- Ability to read and understand English Language
- Ability to provide informed consent
Exclusion Criteria:
- Unstable medical illness within the last month (30 days)
- Acute / recent upper airway infection
- Prior use of non-continuous positive airway pressure medical technology therapies prescribed by a physician for the management of obstructive sleep disordered breathing (e.g., Provent®, Winx™, mandibular advancement oral appliances, etc.)
- Prior use or exposure to CPAP / Bi-Level / or other non-invasive ventilatory modalities
- Craniofacial or other anatomical anomalies that may predispose patients to upper airway obstruction, or obvious blockage to nasal air flow
- Patients using opioids or amphetamines will be excluded from the study.
- Enhanced oxygen requirement (i.e., FiO2>0.21)
- Patients requiring Bi-Level therapy upon CPAP titration attempt
- Surgery since the diagnostic PSG
- Significant recent sedative/hypnotic use likely, in the opinion of the principle investigator, to impair ventilatory control or impact the subsequent titration of either CPAP therapy or Flowrest therapy (including benzodiazepines, antihistamines, imidazopyridines)
- Significant use of stimulant medications likely, in the opinion of the principle investigator, likely to alter ventilatory or upper airway control and impact the subsequent titration of either CPAP therapy or Flowrest therapy (including amphetamines, high dose caffeine, etc.)
- Significant neurologic or cardiac pathology likely to seriously impact respiratory effort or ventilatory control (e.g., post CVA with ventilatory impairment)
- Presence of significant sleep disorders likely to induce hypersomnolence or interfere with the ability to titrate CPAP therapy or Flowrest therapy (including narcolepsy, PLMS/RLS, severe chronic insomnia, non-OSA obesity hypoventilation syndrome, etc.)
- Unsuitable for inclusion in the opinion of the investigators
Sites / Locations
- Sleep Disorders Centers of the Mid-Atlantic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CPAP First / HFT Second
HFT First / CPAP Second
Arm Description
Subjects to receive both therapies, order-randomized to receive Continuous Positive Airway Pressure (CPAP) therapy study first, followed by a washout period, and a follow-on High-Flow Therapy (HFT) therapy study
Subjects to receive both therapies, order-randomized to receive High-Flow Therapy (HFT) therapy study first, followed by a washout period, and a follow-on Continuous Positive Airway Pressure (CPAP) therapy study.
Outcomes
Primary Outcome Measures
AHI Change (Therapy v Baseline)
Evaluate the change in AHI from baseline for HFT v CPAP therapy
Secondary Outcome Measures
Pulse Oxygen Saturation
Evaluate the mean, absolute minimum, absolute event-related nadir and mean nadir of pulse oxygen saturation during therapeutic polysomnography of HFT v CPAP
Sleep Architecture (WASO, %W, N1, N2, N3, REM, SL, RL, AI)
Evaluate changes in sleep architecture on HFT and CPAP therapy as compared to baseline diagnostic polysomnography. Specifically, evaluate any difference between the therapies on %Wake Time (of SPT), % time in stages N1, N2, N3, REM (of TST), Minutes of Wake After Sleep onset, Sleep latency and REM Latency. Any difference in overall non-respiratory arousal index will be assessed.
Respiratory Event Related Arousals
Compare the incidence of RERA on HFT and CPAP therapy as compared to diagnostic polysomnography.
Respiratory Disturbance Index (RDI)
Evaluate the RDI on HFT v CPAP therapy as compared to the diagnostic polysomnography.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01860560
Brief Title
Non-Inferiority Trial of Acute HFT Versus nCPAP
Official Title
Effect of High Flow Nasal Cannula (Flowrest®) on Mild-Moderate Sleep Disordered Breathing: A Non-Inferiority Study Versus Nasal Continuous Positive Airway Pressure (CPAP) Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
this was an error. Study never initiated
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vapotherm, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).
Detailed Description
Study to evaluate the acute efficacy of a single night of High Flow Therapy (HFT) to treat mild-moderate predominantly obstructive Sleep Disordered Breathing, as compared to nasal Continuous Positive Airway Pressure (CPAP) therapy. Subjects will be order-randomized to receive HFT or CPAP in the laboratory, undergo a washout period, and return for the alternative therapy in the laboratory. The hypothesis is that HFT will be non-inferior to CPAP in controlling Apnea/Hypopnea events in this subject set during this study.
Primary outcome will be Apnea / Hypopnea Index (AHI) change on therapy as compared to baseline diagnostic polysomnography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild-Moderate Obstructive Sleep Disordered Breathing
Keywords
OSA, Obstructive Sleep Apnea, High Flow Therapy, CPAP, HFT, Continuous Positive Airway Pressure, Mild OSA, Moderate OSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP First / HFT Second
Arm Type
Experimental
Arm Description
Subjects to receive both therapies, order-randomized to receive Continuous Positive Airway Pressure (CPAP) therapy study first, followed by a washout period, and a follow-on High-Flow Therapy (HFT) therapy study
Arm Title
HFT First / CPAP Second
Arm Type
Experimental
Arm Description
Subjects to receive both therapies, order-randomized to receive High-Flow Therapy (HFT) therapy study first, followed by a washout period, and a follow-on Continuous Positive Airway Pressure (CPAP) therapy study.
Intervention Type
Device
Intervention Name(s)
High-Flow Therapy
Other Intervention Name(s)
Vapotherm Flowrest High Flow Therapy
Intervention Description
Blower-based High Flow Therapy delivered by nasal cannula
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure
Other Intervention Name(s)
Respironics Synchrony Lab
Intervention Description
CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.
Primary Outcome Measure Information:
Title
AHI Change (Therapy v Baseline)
Description
Evaluate the change in AHI from baseline for HFT v CPAP therapy
Time Frame
Acute - single night therapy exposure
Secondary Outcome Measure Information:
Title
Pulse Oxygen Saturation
Description
Evaluate the mean, absolute minimum, absolute event-related nadir and mean nadir of pulse oxygen saturation during therapeutic polysomnography of HFT v CPAP
Time Frame
Acute single night therapy exposure
Title
Sleep Architecture (WASO, %W, N1, N2, N3, REM, SL, RL, AI)
Description
Evaluate changes in sleep architecture on HFT and CPAP therapy as compared to baseline diagnostic polysomnography. Specifically, evaluate any difference between the therapies on %Wake Time (of SPT), % time in stages N1, N2, N3, REM (of TST), Minutes of Wake After Sleep onset, Sleep latency and REM Latency. Any difference in overall non-respiratory arousal index will be assessed.
Time Frame
Acute single night therapy exposure
Title
Respiratory Event Related Arousals
Description
Compare the incidence of RERA on HFT and CPAP therapy as compared to diagnostic polysomnography.
Time Frame
Acute single night therapy exposure
Title
Respiratory Disturbance Index (RDI)
Description
Evaluate the RDI on HFT v CPAP therapy as compared to the diagnostic polysomnography.
Time Frame
Acute single night therapy exposure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
Previous diagnosis of primarily obstructive mild-moderate Sleep Disordered Breathing during in-laboratory polysomnography
Ability to read and understand English Language
Ability to provide informed consent
Exclusion Criteria:
Unstable medical illness within the last month (30 days)
Acute / recent upper airway infection
Prior use of non-continuous positive airway pressure medical technology therapies prescribed by a physician for the management of obstructive sleep disordered breathing (e.g., Provent®, Winx™, mandibular advancement oral appliances, etc.)
Prior use or exposure to CPAP / Bi-Level / or other non-invasive ventilatory modalities
Craniofacial or other anatomical anomalies that may predispose patients to upper airway obstruction, or obvious blockage to nasal air flow
Patients using opioids or amphetamines will be excluded from the study.
Enhanced oxygen requirement (i.e., FiO2>0.21)
Patients requiring Bi-Level therapy upon CPAP titration attempt
Surgery since the diagnostic PSG
Significant recent sedative/hypnotic use likely, in the opinion of the principle investigator, to impair ventilatory control or impact the subsequent titration of either CPAP therapy or Flowrest therapy (including benzodiazepines, antihistamines, imidazopyridines)
Significant use of stimulant medications likely, in the opinion of the principle investigator, likely to alter ventilatory or upper airway control and impact the subsequent titration of either CPAP therapy or Flowrest therapy (including amphetamines, high dose caffeine, etc.)
Significant neurologic or cardiac pathology likely to seriously impact respiratory effort or ventilatory control (e.g., post CVA with ventilatory impairment)
Presence of significant sleep disorders likely to induce hypersomnolence or interfere with the ability to titrate CPAP therapy or Flowrest therapy (including narcolepsy, PLMS/RLS, severe chronic insomnia, non-OSA obesity hypoventilation syndrome, etc.)
Unsuitable for inclusion in the opinion of the investigators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Dungan, MPhil Med
Organizational Affiliation
Vapotherm, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sleep Disorders Centers of the Mid-Atlantic
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Non-Inferiority Trial of Acute HFT Versus nCPAP
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