Sleep Apnea, ObstructivePhase 1/2SATERNCT01061476
Sleep Apnea Treatment With Expiratory Resistance(Provent™)
A Phase 1/2 study testing Treatment sleep study (Provent™ device used), Baseline sleep study (No device) and Physiology sleep study (Provent™ on/off) in people with Sleep Apnea, Obstructive, run by Johns Hopkins University at 1 site in United States.
Trial summary
Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Treatment sleep study (Provent™ device used), Baseline sleep study (No device) and Physiology sleep study (Provent™ on/off)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting adults over the age of 18
- Diagnosed obstructive sleep apnea (defined as an RDI > 5 events per hour \& ≥ 90% of disordered breathing events classified as obstructive)
Who cannot join
- Total sleep time from previous sleep study < 4 hours (240 minutes)
- Severe bilateral nasal obstruction (apparent mouth breathing at rest)
- Documented history of lung diseases, as defined below:
- Daytime hypercapnia (PaCO2 > 45 mmHg)
- Baseline SaO2 ≤ 92%
- Chronic lung disease except mild intermittent or mild persistent asthma
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- Cor pulmonale
- Documented clinical cardiovascular disease, as defined below:
- Myocardial infarction in past 3 months
- Revascularization procedure in past 3 months
- Implanted cardiac pacemaker or ICD
- Unstable arrhythmias
- Congestive heart failure with ejection fraction < 40%
- Uncontrolled hypertension (BP > 190/110)
- History of end stage renal disease (on dialysis)
- History of end stage liver disease, such as:
- Jaundice
- Ascites
- History of recurrent gastrointestinal bleeding
- Transjugular intrahepatic portosystemic shunt (TIPS) ;
- Sleep disorders other than obstructive sleep apnea, such as:
- Narcolepsy
- Restless leg syndrome
- Periodic limb movements causing an arousal index of > 5 per hour
- Transportation industry worker (commercial truck or bus drivers, airline pilots)
- Known pregnancy (by self report)
- Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin.
- Allergy to lidocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224
About this study
Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the current study is to examine how well the Provent™ device treats OSA with particular attention to the how the it may treat sleep apnea and who may most likely benefit from the use of this treatment.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Treatment sleep study (Provent™ device used), Baseline sleep study (No device), Physiology sleep study (Provent™ on/off)
- Keywords
- sleep apnea, treatment, collapsibility, expiratory nasal resistance
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment sleep study (Provent™ device used)Device
The patient's sleep apnea severity is determined on this night while using the Provent™ device. The patient only uses the Provent™ device on this night (single night use only).
Baseline sleep study (No device)Other
The patient sleeps for 1 night in the sleep lab to determine their baseline sleep apnea severity without sleeping with the Provent device.
Physiology sleep study (Provent™ on/off)Other
During this sleep study night, the patient is sleeping with a modified Provent™ device that can be turned on and off to assess changes in airflow during the night (single night use only).Provent™ on/off is bracketed in 10 minute intervals during stable stage 2 sleep.
| Study group | Role | What they receive |
|---|---|---|
| Single arm - Sleep apnea | Other | Participants with sleep apnea will be recruited for the study. Each participant will undergo 3 sleep studies to assess the effect of the Provent™ device. Participants will only use the device while they are in the sleep laboratory. They will not use the device at home between sleep studies .
1. Baseline sleep study (No device) - Assess the effects of no Provent™ on sleep apnea severity.
2. Treatment sleep study (Provent™ device used) - Assess the effects of Provent™ on sleep apnea severity
3. Physiology sleep study (Provent™ on/off) - Assess the physiological effects of the Provent™ device on breathing during sleep. Receives: Device: Treatment sleep study (Provent™ device used); Other: Baseline sleep study (No device); Other: Physiology sleep study (Provent™ on/off) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AHI
The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI > 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and > 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).
Measured: Comparisons were made between the 2 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 1/2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed, Ventus Medical, Inc.
- Responsible party
- Principal investigator, Susheel Patil, Johns Hopkins University
- Investigators
- Susheel Patil, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061476
- Sponsor's protocol ID
- NA_00031257
- Acronym
- SATER
- Status last verified
- Jul 2013
- First submitted
- 2 Feb 2010
- Last updated
- 19 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Colrain IM, Brooks S, Black J. A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea. J Clin Sleep Med. 2008 Oct 15;4(5):426-33.
PubMed 18853699
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea Treatment With Expiratory Resistance(Provent™)
- ClinicalTrials.gov ID
- NCT01061476
- Acronym / sponsor ID
- SATER / NA_00031257
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- sleep apnea, treatment, collapsibility, expiratory nasal resistance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- ResMed, Ventus Medical, Inc.
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Posted 8 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuous positive airway pressure (CPAP) continues to be the primary therapy prescribed for the treatment of obstructive sleep apnea (OSA). Although effective, adherence to CPAP is suboptimal in many patients, making alternative therapies desirable. Recently, a novel device (Provent™) has been developed for the treatment of snoring and OSA. The purpose of the current study is to examine how well the Provent™ device treats OSA with particular attention to the how the it may treat sleep apnea and who may most likely benefit from the use of this treatment.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm - Sleep apnea | Other | Device: Treatment sleep study (Provent™ device used), Other: Baseline sleep study (No device), Other: Physiology sleep study (Provent™ on/off)Participants with sleep apnea will be recruited for the study. Each participant will undergo 3 sleep studies to assess the effect of the Provent™ device. Participants will only use the device while they are in the sleep laboratory. They will not use the device at home between sleep studies . 1. Baseline sleep study (No device) - Assess the effects of no Provent™ on sleep apnea severity. 2. Treatment sleep study (Provent™ device used) - Assess the effects of Provent™ on sleep apnea severity 3. Physiology sleep study (Provent™ on/off) - Assess the physiological effects of the Provent™ device on breathing during sleep. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consenting adults over the age of 18
- Diagnosed obstructive sleep apnea (defined as an RDI > 5 events per hour \& ≥ 90% of disordered breathing events classified as obstructive)
Key exclusion criteria (28 listed)
- Total sleep time from previous sleep study < 4 hours (240 minutes)
- Severe bilateral nasal obstruction (apparent mouth breathing at rest)
- Documented history of lung diseases, as defined below:
- Daytime hypercapnia (PaCO2 > 45 mmHg)
- Baseline SaO2 ≤ 92%
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 |
|---|---|---|
| Treatment sleep study (Provent™ device used)The patient's sleep apnea severity is determined on this night while using the Provent™ device. The patient only uses the Provent™ device on this night (single night use only). | Device | Single arm - Sleep apnea |
| Baseline sleep study (No device)The patient sleeps for 1 night in the sleep lab to determine their baseline sleep apnea severity without sleeping with the Provent device. | Other | Single arm - Sleep apnea |
| Physiology sleep study (Provent™ on/off)During this sleep study night, the patient is sleeping with a modified Provent™ device that can be turned on and off to assess changes in airflow during the night (single night use only).Provent™ on/off is bracketed in 10 minute intervals during stable stage 2 sleep. | Other | Single arm - Sleep apnea |
Primary outcome
Change in AHI
Time frame: Comparisons were made between the 2 nights
The primary outcome was the change in the apnea hypopnea index (AHI). Sleep apnea events are defined as apneas and hypopneas.The AHI is a measure of sleep apnea severity. An AHI > 5 event/h is considered abnormal. AHI values are typically categorized as 5-15 events/hr = mild; 15-30 events/hr = moderate; and > 30 events/hr = severe. For this study we compared the change in AHI from the baseline sleep study (No Provent) compared to the treatment night sleep study (on Provent).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18853699Colrain IM, Brooks S, Black J. A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea. J Clin Sleep Med. 2008 Oct 15;4(5):426-33.
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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.
Susheel Patil, MD, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Treatment sleep study (Provent™ device used), Baseline sleep study (No device) and Physiology sleep study (Provent™ on/off) in people with Sleep Apnea, Obstructive, run by Johns Hopkins University 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 2 inclusion and 28 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: finished, as of the sponsor's last update on 19 Jul 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in AHI (time frame: Comparisons were made between the 2 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01061476, which also lists 1 linked publication.
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 19 Jul 2013.