Non-Inferiority Trial of Acute HFT Versus nCPAP

Mild-Moderate Obstructive Sleep Disordered Breathing Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01860560
• Other study ID #: RP-HFR2013001Reg
• Status: Withdrawn
• Phase: N/A
• Start date: May 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2023
• Source: Vapotherm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mild-Moderate Obstructive Sleep Disordered Breathing
• Respiratory Aspiration
• Sleep Apnea Syndromes

Intervention

Device:
• High-Flow Therapy
Blower-based High Flow Therapy delivered by nasal cannula
• Continuous Positive Airway Pressure
CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.

Locations

Country	Name	City	State
United States	Sleep Disorders Centers of the Mid-Atlantic	Glen Burnie	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Vapotherm, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AHI Change (Therapy v Baseline)	Evaluate the change in AHI from baseline for HFT v CPAP therapy	Acute - single night therapy exposure
Secondary	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
Secondary	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
Secondary	Respiratory Event Related Arousals	Compare the incidence of RERA on HFT and CPAP therapy as compared to diagnostic polysomnography.	Acute single night therapy exposure
Secondary	Respiratory Disturbance Index (RDI)	Evaluate the RDI on HFT v CPAP therapy as compared to the diagnostic polysomnography.	Acute single night therapy exposure