Obstructive Sleep Apnea
Conditions
Keywords
Obstructive sleep apnea, Mouth breathing, Apnea-Hypopnea Index (AHI)
Brief 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. 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.
Interventions
DEVICEVarnum mouthpiece
An adhesive mouthpiece with a central opening applied during sleep
Sponsors
David Andrew Wellman
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Presence of obstructive sleep apnea (AHI\>10 events/hr)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep | Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece | 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. |
| Snoring Index in Simple Snorers | Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polysomnogram With Varnum First, Regular Polysomnogram Second 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. | 11 |
| Regular Polysomnogram First, Polysomnogram With Varnum Second 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. | 15 |
| Total | 26 |
Baseline characteristics
| Characteristic | Polysomnogram With Varnum First, Regular Polysomnogram Second | Regular Polysomnogram First, Polysomnogram With Varnum Second | Total |
|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 13.4 | 55.3 years STANDARD_DEVIATION 8.1 | 54.8 years STANDARD_DEVIATION 10.4 |
| Apnea-Hypopnea Index | 17.0 Events/hour STANDARD_DEVIATION 14.3 | 25.5 Events/hour STANDARD_DEVIATION 18.1 | 21.9 Events/hour STANDARD_DEVIATION 16.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 11 Participants | 18 Participants |
| Region of Enrollment United States | 11 participants | 15 participants | 26 participants |
| Sex: Female, Male Female | 2 Participants | 9 Participants | 11 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 15 Participants |
| Snoring Index | 36.0 Events/hour STANDARD_DEVIATION 57.9 | 331.2 Events/hour STANDARD_DEVIATION 271.7 | 146.7 Events/hour STANDARD_DEVIATION 215.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
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.
Time frame: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Polysomnogram With Varnum Mouthpiece | Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) | 16.4 Events/hour |
| Regular Polysomnogram | Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) | 15.8 Events/hour |
Secondary
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.
Time frame: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Polysomnogram With Varnum Mouthpiece | Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep | 0.32 L/s |
| Regular Polysomnogram | Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep | 0.36 L/s |
Secondary
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.
Time frame: Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece
Population: This outcome was only calculated for simple snorers with AHI\<10 events/hour.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Polysomnogram With Varnum Mouthpiece | Snoring Index in Simple Snorers | 3.0 Snore/hour |
| Regular Polysomnogram | Snoring Index in Simple Snorers | 30.4 Snore/hour |