N/A
Completed N=26
Effect of Added Varnum Mouthpiece on Pharyngeal Collapsibility and Sleep Apnea Severity in Mouth Breathers.
Source: ClinicalTrials.gov NCT02738255 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI) — 16.4; 15.8 Events/hour
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.
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 | — |
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. Informational only — not medical advice.