Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

NCT02109731 | Completed Results DMC

• 1 other identifier: 24149
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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}

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea Syndrome (OSAS); Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG)

  The pre-study AHI (before the NAP treatment was applied) was measured and quantified and compared to the post study AHI (after three months of NAP treatment) and the difference between pre and post therapy is reported. The AHI is an hourly rate of breathing disturbance (apneas and hypopneas per hour) that is calculated while subjects are evaluated during an overnight sleep study, with polysomnography applied (PSG). For example, while a subject is spending the night in the PSG laboratory sleeping, his/her breathing is evaluated for evidence of apneas and hypopneas during various stages of sleep. Sleep is measured with electroencephalography. And breathing is measure with respiratory excursions via chest/abdominal plethysmography recordings and airflow from the nose/mouth.

  three months

Study Arms (1)

Negative airway pressure delivery

EXPERIMENTAL

Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.

Other: Negative airway pressure delivery

Interventions

Negative airway pressure delivery OTHER

Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.

Negative airway pressure delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. Suzanne Karan
• Organization: University of Rochester

suzanne_karan@urmc.rochester.edu

5852751384

Study Officials

• Suzanne Karan, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 9, 2012
• First Posted: April 10, 2014
• Study Start: January 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 15, 2015
• Results First Posted: March 25, 2015

Record last verified: 2015-03

Locations

US (1)