Non-Inferiority Trial of Acute HFT Versus nCPAP

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Mild-Moderate Obstructive Sleep Disordered Breathing
• Intervention / Treatment: Device: High-Flow Therapy; Device: Continuous Positive Airway Pressure

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Sleep Disorders Centers of the Mid-Atlantic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP First / HFT Second; 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	Device: High-Flow Therapy; Blower-based High Flow Therapy delivered by nasal cannula; Other Names: Vapotherm Flowrest High Flow Therapy; Device: Continuous Positive Airway Pressure; CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.; Other Names: Respironics Synchrony Lab
Experimental: HFT First / CPAP Second; 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.	Device: High-Flow Therapy; Blower-based High Flow Therapy delivered by nasal cannula; Other Names: Vapotherm Flowrest High Flow Therapy; Device: Continuous Positive Airway Pressure; CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.; Other Names: Respironics Synchrony Lab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AHI Change (Therapy v Baseline)	Evaluate the change in AHI from baseline for HFT v CPAP therapy	Acute - single night therapy exposure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Acute single night therapy exposure
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.	Acute single night therapy exposure
Respiratory Event Related Arousals	Compare the incidence of RERA on HFT and CPAP therapy as compared to diagnostic polysomnography.	Acute single night therapy exposure
Respiratory Disturbance Index (RDI)	Evaluate the RDI on HFT v CPAP therapy as compared to the diagnostic polysomnography.	Acute single night therapy exposure

Collaborators and Investigators

• Sponsor: Vapotherm, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure; OSA; Obstructive Sleep Apnea; CPAP; High Flow Therapy; HFT; Mild OSA; Moderate OSA
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Respiratory Aspiration
• Other Study ID Numbers: RP-HFR2013001Reg