Trial Outcomes & Findings for Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea (NCT NCT02109731)

NCT ID: NCT02109731

Last Updated: 2015-04-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: three months
• Results posted on: 2015-04-15

Participant Flow

Participant milestones

Measure	Negative Airway Pressure Delivery 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: 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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Upper Airway Physical Therapy for the Treatment of Obstructive Sleep Apnea

Baseline characteristics by cohort

Measure	Negative Airway Pressure Delivery n=15 Participants 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: 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.
Age, Continuous	57.8 years STANDARD_DEVIATION 13.27 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
BMI	32.9 kilograms per meter squared STANDARD_DEVIATION 6.3 • n=5 Participants

PRIMARY outcome

Timeframe: three months

Population: subjects with a diagnosis of OSA

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.

Outcome measures

Measure

Negative Airway Pressure Delivery n=15 Participants 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: 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.

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

4.27 events per hour Standard Deviation 11.96

Adverse Events

Negative Airway Pressure Delivery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Suzanne Karan

University of Rochester

Phone: 5852751384

Email: suzanne_karan@urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place