Non-Inferiority Trial of Acute HFT Versus nCPAP

NCT01860560 | Withdrawn

• 1 other identifier: RP-HFR2013001Reg
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild-Moderate Obstructive Sleep Disordered Breathing

Keywords

OSA; Obstructive Sleep Apnea; High Flow Therapy; CPAP; HFT; Continuous Positive Airway Pressure; Mild OSA; Moderate OSA

Outcome Measures

Primary Outcomes (1)

• AHI Change (Therapy v Baseline)

  Evaluate the change in AHI from baseline for HFT v CPAP therapy

  Acute - single night therapy exposure

Secondary Outcomes (4)

• Pulse Oxygen Saturation

  Acute single night therapy exposure

• Sleep Architecture (WASO, %W, N1, N2, N3, REM, SL, RL, AI)

  Acute single night therapy exposure

• Respiratory Event Related Arousals

  Acute single night therapy exposure

• Respiratory Disturbance Index (RDI)

  Acute single night therapy exposure

Study Arms (2)

CPAP First / HFT Second

EXPERIMENTAL

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; Device: Continuous Positive Airway Pressure

HFT First / CPAP Second

EXPERIMENTAL

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; Device: Continuous Positive Airway Pressure

Interventions

High-Flow Therapy DEVICE

Blower-based High Flow Therapy delivered by nasal cannula

Also known as: Vapotherm Flowrest High Flow Therapy

CPAP First / HFT Second; HFT First / CPAP Second

Continuous Positive Airway Pressure DEVICE

CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.

Also known as: Respironics Synchrony Lab

CPAP First / HFT Second; HFT First / CPAP Second

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Vapotherm, Inc.: lead

Study Sites (1)

Sleep Disorders Centers of the Mid-Atlantic

Glen Burnie, Maryland, 21061, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• George Dungan, MPhil Med

  Vapotherm, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 22, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

US (1)