Airway Muscle Training for Obstructive Sleep Apnea

NCT02259660 | Completed

• 1 other identifier: IRB201400642
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if muscle training will improve snoring and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity of their apnea. After this study, subjects will be randomly assigned to one of two groups. The first group will receiving a breathing trainer that may strengthen the muscles used to breath in and out. The second group will be receive a sham trainer which looks like the "real" trainer but is not able to produce a strengthening effect. Both groups will complete eight weeks of home based (real or sham) training. The sleep study will be repeated and we well measure any changes in measures of severity for obstructive sleep apnea.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; osa; breathing; snoring; respiratory; exercise; inspiratory muscle strength training; expiratory muscle strength training

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI)

  The AHI is a measure of symptom severity for obstructive sleep apnea. Physiological data obtained during a sleep study is used to complete this measure.

  Baseline and 10 weeks

Secondary Outcomes (2)

• Maximum inspiratory pressure (MIP)

  Baseline and 10 weeks

• Maximum expiratory pressure (MEP)

  Baseline and 10 weeks

Study Arms (2)

Active Group

ACTIVE COMPARATOR

Subjects in this arm will train their respiratory muscles at home. The training protocol will use progressively higher pressure threshold training valves to provide respiratory muscle strength training at a pressure threshold greater than 70% maximum inspiratory (MIP) and expiratory (MEP) pressures. The total daily training time should be 20 to 30 minutes in duration.

Device: Respiratory muscle strength training

Sham Training

PLACEBO COMPARATOR

The intervention in the sham training arm will be identical in every way to that of the active arm with the exception of the trainer that is provided. Subjects in the sham training arm will have inspiratory and expiratory muscle strength trainers which have had the pressure threshold spring removed and are therefore unable to provide a load to the muscles being trained.

Device: Sham respiratory muscle strength training

Interventions

Respiratory muscle strength training DEVICE

Inspiratory and expiratory muscle strength training occur when subjects are required to breath in (as with inspiratory training) or out (as with expiratory training) through a pressure threshold device. This device features a spring-loaded one way valve which will only open if the subject is able to generate sufficient air pressure to overcome a predetermined pressure threshold. This threshold is typically set at 75% of the subject's maximum capacity. Repeatedly overcoming this threshold during training produces a strengthening effect in most people.

Also known as: Inspiratory muscle strength training, Expiratory muscle strength training

Active Group

Sham respiratory muscle strength training DEVICE

The placebo / sham intervention will mimic the active intervention(s) in every respect except the devices used will be rendered neutral via removal of the pressure threshold spring inside the devices.

Also known as: Sham inspiratory muscle strength training, Sham expiratory muscle strength training

Sham Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years,
• AHI ≥ 5/hour and less than 30/hour
• Ability to understand and perform training.
• Ability to return to the UFHealth Sleep Center 1X per week for the (8 week) duration of the study.

You may not qualify if:

• Pregnancy
• Prior Upper airway surgery (nasal surgery is allowed)
• Severe nasal obstruction
• BMI \> 35 kg/M2
• Use of potent narcotics
• History of arrhythmia (other than PACs and PVCs)
• Coronary artery disease or congestive heart failure (patients with controlled hypertension will be included),
• Moderate to severe lung disease
• History of pneumothorax.10. severe daytime sleepiness (falling asleep while driving or
• Epworth Sleepiness Scale \[Appendix 1\] \> 14),
• History of chronic short sleep duration (\< 5 hours).

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UFHealth Sleep Center

Gainesville, Florida, 32606, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Respiratory Aspiration; Snoring; Motor Activity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Study Officials

• Richard Berry, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 8, 2014
• Study Start: April 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 28, 2017
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

US (1)