N/A
N=26
Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02738255 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) — 16.4; 15.8 Events/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Varnum mouthpiece (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- David Andrew Wellman
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) |
16.4; 15.8 | — |
| SECONDARY Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep |
0.32; 0.36 | — |
| SECONDARY Snoring Index in Simple Snorers |
3.0; 30.4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02738255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.