N/A N=15 Treatment

Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02109731 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG) — 4.27 events per hour

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Negative airway pressure delivery (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Rochester
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG)	4.27	—

Summary

The purpose of this study is to determine the effectiveness and feasibility of upper airway muscle physical therapy utilizing negative airway pressure (NAP) breathing training in patients with Obstructive Sleep Apnea Syndrome (OSAS) in reducing both signs (apnea hypopnea index) and symptoms (i.e., daytime sleepiness).The key to the proposed therapy is the use of Negative Air Pressure when awake so that the increased reflex phasic drive to the muscles will result in muscle conditioning. Interestingly, other studies have indicated that upper airway muscle training may be useful in treating OSAS, but these studies used techniques that were not scientifically designed{Puhan, 2006 8195 /id} or used a technique (electrical stimulation) that was not well tolerated.{Lequeux, 2005 7514 /id}

Eligibility Criteria

Inclusion Criteria

18 and over and any persons who have been diagnosed with OSAS (AHI over 15) and who are not utilizing CPAP

Exclusion Criteria

Participants will be excluded if: Pregnant, Breastfeeding or any bleeding abnormalities, there is a major upper airway morphologic abnormality (e.g., retrognathia, Pierre-Robin syndrome), they have had any airway surgery (except tonsillectomy as a child),they regularly use any drugs that are known to depress the central nervous system (such as benzodiazepines, narcotics), they consume 14 alcoholic drinks a week or 2 a day,they are undergoing a current or planned intervention for weight reduction or are morbidly obese (body mass index 40 kg/m2), or they have any unstable medical or psychiatric illnesses.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02109731). 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.