Mild-Moderate Obstructive Sleep Disordered BreathingNCT01860560
Non-Inferiority Trial of Acute HFT Versus nCPAP
A study testing High-Flow Therapy and Continuous Positive Airway Pressure in people with Mild-Moderate Obstructive Sleep Disordered Breathing, run by Vapotherm, Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild-Moderate Obstructive Sleep Disordered Breathing
- What is being tested?
- High-Flow Therapy and Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Disorders Centers of the Mid-Atlantic
Glen Burnie, Maryland, 21061
About this study
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
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).
Read the 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.
- Being tested
- High-Flow Therapy, Continuous Positive Airway Pressure
- Keywords
- OSA, Obstructive Sleep Apnea, High Flow Therapy, CPAP, HFT, Continuous Positive Airway Pressure, Mild OSA, Moderate OSA
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow TherapyDevice
Also called Vapotherm Flowrest High Flow Therapy
Blower-based High Flow Therapy delivered by nasal cannula
Continuous Positive Airway PressureDevice
Also called Respironics Synchrony Lab
CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: High-Flow Therapy; Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI Change (Therapy v Baseline)
Evaluate the change in AHI from baseline for HFT v CPAP therapy
Measured: Acute - single night therapy exposure
Secondary outcomes (4)
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
Measured: 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.
Measured: Acute single night therapy exposure
Respiratory Event Related Arousals
Compare the incidence of RERA on HFT and CPAP therapy as compared to diagnostic polysomnography.
Measured: Acute single night therapy exposure
Respiratory Disturbance Index (RDI)
Evaluate the RDI on HFT v CPAP therapy as compared to the diagnostic polysomnography.
Measured: Acute single night therapy exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: this was an error. Study never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild-Moderate Obstructive Sleep Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vapotherm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Dungan, MPhil Med, Study director, Vapotherm, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860560
- Sponsor's protocol ID
- RP-HFR2013001Reg
- Status last verified
- Apr 2023
- First submitted
- 16 May 2013
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01860560
- Acronym / sponsor ID
- RP-HFR2013001Reg
- Keywords
- OSA, Obstructive Sleep Apnea, High Flow Therapy, CPAP, HFT, Continuous Positive Airway Pressure, Mild OSA, Moderate OSA
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: this was an error. Study never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vapotherm, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP First / HFT Second | Experimental | Device: High-Flow Therapy, Device: Continuous Positive Airway PressureSubjects 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 |
| HFT First / CPAP Second | Experimental | Device: High-Flow Therapy, Device: Continuous Positive Airway PressureSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Flow TherapyAlso: Vapotherm Flowrest High Flow TherapyBlower-based High Flow Therapy delivered by nasal cannula | Device | CPAP First / HFT Second, HFT First / CPAP Second |
| Continuous Positive Airway PressureAlso: Respironics Synchrony LabCPAP Therapy delivered by laboratory Positive Airway Pressure titration device. | Device | CPAP First / HFT Second, HFT First / CPAP Second |
Primary outcome
AHI Change (Therapy v Baseline)
Time frame: Acute - single night therapy exposure
Evaluate the change in AHI from baseline for HFT v CPAP therapy
4 secondary outcomes
Pulse Oxygen Saturation
Time frame: Acute single night therapy exposure
Sleep Architecture (WASO, %W, N1, N2, N3, REM, SL, RL, AI)
Time frame: Acute single night therapy exposure
Respiratory Event Related Arousals
Time frame: Acute single night therapy exposure
Respiratory Disturbance Index (RDI)
Time frame: Acute single night therapy exposure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
Related trials for Mild-Moderate Obstructive Sleep Disordered Breathing
Not yet recruiting
Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).
Snoring, OSA - Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Dungan, MPhil Med study director
Vapotherm, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Flow Therapy and Continuous Positive Airway Pressure in people with Mild-Moderate Obstructive Sleep Disordered Breathing, run by Vapotherm, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI Change (Therapy v Baseline) (time frame: Acute - single night therapy exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.