Non-Inferiority Trial of Acute HFT Versus nCPAP

NCT ID: NCT01860560

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-01-31

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.

Conditions

Mild-Moderate Obstructive Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

High-Flow Therapy

Intervention Type: DEVICE

Blower-based High Flow Therapy delivered by nasal cannula

Continuous Positive Airway Pressure

Intervention Type: DEVICE

CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.

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.

Group Type: EXPERIMENTAL

High-Flow Therapy

Intervention Type: DEVICE

Blower-based High Flow Therapy delivered by nasal cannula

Continuous Positive Airway Pressure

Intervention Type: DEVICE

CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.

Interventions

High-Flow Therapy

Blower-based High Flow Therapy delivered by nasal cannula

Intervention Type: DEVICE

Continuous Positive Airway Pressure

CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.

Intervention Type: DEVICE

Other Intervention Names

Vapotherm Flowrest High Flow Therapy; Respironics Synchrony Lab

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vapotherm, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Dungan, MPhil Med

Role: STUDY_DIRECTOR

Vapotherm, Inc.

Locations

Sleep Disorders Centers of the Mid-Atlantic

Glen Burnie, Maryland, United States

Countries

United States

Other Identifiers

RP-HFR2013001Reg

Identifier Type: -

Identifier Source: org_study_id