Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

Intervention name(s): Varnum mouthpiece
Intervention type(s): Device
Intervention description(s): An adhesive mouthpiece with a central opening applied during sleep
Other intervention name(s): Somnifix mouthpiece
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; Mouth breathing; Apnea-Hypopnea Index (AHI)