Obstructive Sleep ApneaNCT02738255
Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
A study testing Varnum mouthpiece in people with Obstructive Sleep Apnea, run by David Andrew Wellman at 1 site in United States.
Trial summary
Test the effect of added a single-use Varnum mouthpiece on pharyngeal collapsibility and obstructive sleep apnea (OSA) severity in patients who identify themselves as mouth breathers. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Varnum mouthpiece
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2016to 15 Jun 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of obstructive sleep apnea (AHI>10 events/hr)
Who cannot join
- Serious co-morbidities including lung disease, heart disease, renal disease
- Medications affecting respiration or sleep
- Mouth breather subgroup inclusion criteria: self-described mouth breathing habit during sleep.
- non-mouth breathing subgroup inclusion criteria: absence of self-described mouth breathing during sleep
Trial locations and contacts
1 site in 1 country.
United States1 site
Sleep Disorders Research Program Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Test the effect of added a single-use Varnum mouthpiece on pharyngeal collapsibility and obstructive sleep apnea (OSA) severity in patients who identify themselves as mouth breathers. Research indicates that nasal breathing not only may improve sleep apnea but it also increases circulation, blood oxygen, and carbon dioxide levels, slows the breathing rate, and improves overall lung volumes. Thus, the investigators will test whether a single-use Varnum mouthpiece can improve pharyngeal collapsibility and OSA severity in mouth breathers.
Read the detailed description
Obstructive sleep apnea (OSA) is a common disorder that remains under-treated due few therapeutic options beyond continuous positive airway pressure (CPAP). In patients with OSA, upper airway obstruction is caused by collapse of pharyngeal structures during sleep. It is known that mouth breathing increases upper-airway collapsibility during sleep and may contribute to the occurrence of sleep disordered breathing. In addition, it was shown that patients with a high percentage of mouth breathing during sleep were less adherent to CPAP therapy. Therefore, one potential solution to these problems is to use Varnum's mouthpiece to prevent mouth breathing during sleep.
The overall objective of the current study is to improve upper airway collapsibility and sleep apnea in OSA patients who have a high percentage of mouth breathing during sleep. The investigators' central hypothesis is that preventing the lips from parting with the Varnum device will reduce oral breathing and thereby OSA severity in mouth breathers. The investigators chose this hypothesis because "taping the mouth closed" with a simple device such as the Varnum mouthpiece is the most straightforward approach to dealing with this common problem. With this research, it could become possible to overcome one of the major problems contributing to sleep apnea - mouth breathing.
Therefore, the investigators aim to test the effect of the Varnum mouthpiece on pharyngeal collapsibility and OSA severity in patients who identify themselves as mouth breathers. The investigators' working hypothesis is that the device will keep the lips from separating and thereby prevent oral breathing. In doing so, it may help keep the airway more patent (by promoting nasal instead of oral breathing) in self-described mouth breathers and thus reduce OSA severity. On the contrary, the investigators believe patients who do not identify themselves as mouth breathers might not benefit significantly from the Varnum device.
The expected outcome of this study is validation of new device for improving sleep apnea in a large subgroup of easily identifiable OSA patients, namely self-described mouth breathers. Such a device could advance the field by providing more effective alternative treatments.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Varnum mouthpiece
- Keywords
- Obstructive sleep apnea, Mouth breathing, Apnea-Hypopnea Index (AHI)
- Medical subject headings
- Sleep Apnea, Obstructive, Mouth Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varnum mouthpieceDevice
Also called Somnifix mouthpiece
An adhesive mouthpiece with a central opening applied during sleep
| Study group | Role | What they receive |
|---|---|---|
| Polysomnogram With Varnum First, Regular Polysomnogram Second | Active comparator | Varnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece. Receives: Device: Varnum mouthpiece |
| Regular Polysomnogram First, Polysomnogram With Varnum Second | Active comparator | Baseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night. Receives: Device: Varnum mouthpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI)
The number of respiratory events (apneas and hypopneas) per hour of sleep. This was measured on two nights in random order (night with Varnum mouthpiece and night without Varnum mouthpiece). The median AHI on the night with Varnum mouthpiece was then compared with median AHI on the night without Varnum mouthpiece.
Measured: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Secondary outcomes (2)
Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep
The median peak flow during sleep was measured and compared on both nights (night with Varnum mouthpiece and night without Varnum mouthpiece). The median peak flow is a surrogate measure of upper airway collapsibility.
Measured: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Snoring Index in Simple Snorers
Snoring index is the number of breaths with snoring per hour of sleep. This was measured in both nights (night with Varnum mouthpiece and night without Varnum mouthpiece) only in simple snorers with AHI<10. The median of snoring index was compared between night with Varnum mouthpiece and night without Varnum mouthpiece.
Measured: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start2 Jun 2016
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
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.
- Other trials for Obstructive Sleep ApneaStudies 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
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Andrew Wellman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Andrew Wellman, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738255
- Sponsor's protocol ID
- 2012P000957F
- Status last verified
- Mar 2022
- First submitted
- 12 Apr 2016
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
- ClinicalTrials.gov ID
- NCT02738255
- Acronym / sponsor ID
- 2012P000957F
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Mouth breathing, Apnea-Hypopnea Index (AHI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- David Andrew WellmanUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Test the effect of added a single-use Varnum mouthpiece on pharyngeal collapsibility and obstructive sleep apnea (OSA) severity in patients who identify themselves as mouth breathers. Research indicates that nasal breathing not only may improve sleep apnea but it also increases circulation, blood oxygen, and carbon dioxide levels, slows the breathing rate, and improves overall lung volumes. Thus, the investigators will test whether a single-use Varnum mouthpiece can improve pharyngeal collapsibility and OSA severity in mouth breathers.
Detailed description
Obstructive sleep apnea (OSA) is a common disorder that remains under-treated due few therapeutic options beyond continuous positive airway pressure (CPAP). In patients with OSA, upper airway obstruction is caused by collapse of pharyngeal structures during sleep. It is known that mouth breathing increases upper-airway collapsibility during sleep and may contribute to the occurrence of sleep disordered breathing. In addition, it was shown that patients with a high percentage of mouth breathing during sleep were less adherent to CPAP therapy. Therefore, one potential solution to these problems is to use Varnum's mouthpiece to prevent mouth breathing during sleep.
The overall objective of the current study is to improve upper airway collapsibility and sleep apnea in OSA patients who have a high percentage of mouth breathing during sleep. The investigators' central hypothesis is that preventing the lips from parting with the Varnum device will reduce oral breathing and thereby OSA severity in mouth breathers. The investigators chose this hypothesis because "taping the mouth closed" with a simple device such as the Varnum mouthpiece is the most straightforward approach to dealing with this common problem. With this research, it could become possible to overcome one of the major problems contributing to sleep apnea - mouth breathing.
Therefore, the investigators aim to test the effect of the Varnum mouthpiece on pharyngeal collapsibility and OSA severity in patients who identify themselves as mouth breathers. The investigators' working hypothesis is that the device will keep the lips from separating and thereby prevent oral breathing. In doing so, it may help keep the airway more patent (by promoting nasal instead of oral breathing) in self-described mouth breathers and thus reduce OSA severity. On the contrary, the investigators believe patients who do not identify themselves as mouth breathers might not benefit significantly from the Varnum device.
The expected outcome of this study is validation of new device for improving sleep apnea in a large subgroup of easily identifiable OSA patients, namely self-described mouth breathers. Such a device could advance the field by providing more effective alternative treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polysomnogram With Varnum First, Regular Polysomnogram Second | Active comparator | Device: Varnum mouthpieceVarnum mouthpiece, similar to a mouth tape with central opening on the first night, then a 1-week non-treatment period, then overnight sleep study with no mouthpiece. |
| Regular Polysomnogram First, Polysomnogram With Varnum Second | Active comparator | Device: Varnum mouthpieceBaseline sleep study without Varnum mouthpiece on the first night, then a 1-week non-treatment period, then an overnight sleep study with Varnum mouthpiece on the second night. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of obstructive sleep apnea (AHI>10 events/hr)
Key exclusion criteria (4 listed)
- Serious co-morbidities including lung disease, heart disease, renal disease
- Medications affecting respiration or sleep
- Mouth breather subgroup inclusion criteria: self-described mouth breathing habit during sleep.
- non-mouth breathing subgroup inclusion criteria: absence of self-described mouth breathing during sleep
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 |
|---|---|---|
| Varnum mouthpieceAlso: Somnifix mouthpieceAn adhesive mouthpiece with a central opening applied during sleep | Device | Polysomnogram With Varnum First, Regular Polysomnogram Second, Regular Polysomnogram First, Polysomnogram With Varnum Second |
Primary outcome
Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI)
Time frame: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
The number of respiratory events (apneas and hypopneas) per hour of sleep. This was measured on two nights in random order (night with Varnum mouthpiece and night without Varnum mouthpiece). The median AHI on the night with Varnum mouthpiece was then compared with median AHI on the night without Varnum mouthpiece.
2 secondary outcomes
Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep
Time frame: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Snoring Index in Simple Snorers
Time frame: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varnum mouthpiece in people with Obstructive Sleep Apnea, run by David Andrew Wellman 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 1 inclusion and 4 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 4 Apr 2022. 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?
Yes. Results are posted in the registry (first posted 3 Jul 2018). 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?
Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) (time frame: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece). 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 4 Apr 2022.