Effects of Upper Airway Muscle Training on OSA

NCT02502942 | Completed DMC

• 2 other identifiers: UCSD130780R01HL085188-05A1
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the upper airway during sleep. OSA patients have a small upper airway that is kept patent during wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g. genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in upper airway narrowing or collapse. Previous studies of upper airway muscle training showed variable results on OSA, but so far there has not been any practical, long-term, systematic upper airway muscle training developed or studied as the treatment of OSA. In theory, strengthening the upper airway muscle with exercise training in theory helps maintain a patent airway during sleep. Therefore, investigators aim to test the hypothesis: 1) UA muscle training can improve sleep apnea in some patients with OSA, including those already receiving treatment with PAP or oral appliance therapy. 2) Muscle training is a viable therapy for a definable subset of OSA patients. Investigators hypothesize that patients with OSA who have mild or moderately compromised upper airway anatomy will benefit the most. 3)There will be a positive association between the changes in muscle function and improvement in OSA severity.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Exercise; Upper airway muscle

Outcome Measures

Primary Outcomes (2)

• Change of severity of obstructive sleep apnea, measured as apnea hypopnea index (AHI), for untreated OSA group and oral appliance group

  Home sleep test is used to measure AHI.

  Baseline and after 6-week exercise training

• Change of severity of obstructive sleep apnea, measured as 95th percentile pressures, for PAP therapy group

  95th percentile pressures (2 week period) of autotitrating CPAP will be used to assess the effects of upper airway muscle exercise on muscle strength.

  Baseline and after 6-week exercise training

Secondary Outcomes (6)

• Change of sleepiness measured by Epworth Sleepiness Scale (ESS)

  Baseline and after 6-week exercise training

• Change of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)

  Baseline and after 6-week exercise training

• Change of subjective quality of life measured by SF-36

  Baseline and after 6-week exercise training

• Change of neurocognitive function measured by psychomotor vigilance test (PVT)

  Baseline and after 6-week exercise training

• Change of upper airway anatomy evaluated with acoustic pharyngometry

  Baseline and after 6-week exercise training

Study Arms (4)

Untreated OSA Muscle Exercise Group

EXPERIMENTAL

Patients who were previously diagnosed of obstructive sleep apnea (OSA) with apnea hypopnea index (AHI) \> 10 events/hr and have previously failed or refused PAP therapy. In this group, patients will learn and practice upper airway muscle exercise for six weeks.

Behavioral: Upper Airway Muscle Exercise

PAP Therapy Muscle Exercise Group

EXPERIMENTAL

OSA patients who are currently treated with PAP for their OSA (with AHI of previous sleep study \> 10 events/hr). In this group, patients will learn and practice upper airway muscle exercise for six weeks.

Behavioral: Upper Airway Muscle Exercise

Oral Appliance Muscle Exercise Group

EXPERIMENTAL

OSA patients who are currently treated with an oral appliance with residual AHI \> 10 events/hr. In this group, patients will learn and practice upper airway muscle exercise for six weeks.

Behavioral: Upper Airway Muscle Exercise

Normal Control Sham Exercise Group

ACTIVE COMPARATOR

Patients of untreated OSA group, PAP therapy group, and oral appliance group are randomized to upper airway muscle exercise versus sham exercise.

Behavioral: Sham Exercise

Interventions

Upper Airway Muscle Exercise BEHAVIORAL

Patients will use an individualized oral retainer device for upper airway muscle training exercises daily for 20 minutes each day (10 minutes in the morning and 10 minutes in the afternoon/evening) for 6 weeks.

Oral Appliance Muscle Exercise Group; PAP Therapy Muscle Exercise Group; Untreated OSA Muscle Exercise Group

Sham Exercise BEHAVIORAL

Patients will be given an individualized oral retainer device and instructed to do deep breathing exercise twice daily for 6 weeks.

Normal Control Sham Exercise Group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior diagnosis of OSA with AHI\>10 events/hr.
• PAP group: subjects who have been on PAP treatment for at least 3 month, with good compliance (at least 4 hours a day and use PAP for \>70% of the time).
• Untreated group: untreated subjects with generally mild OSA as defined by AHI\<20 events/hr and nadir SaO2\>70%. Additionally, investigators will also recruit OSA subjects of all severities who have previously tried but are not currently using PAP.
• Oral appliance treatment group: subjects have residual AHI \>10 events/hr with oral appliance therapy.

You may not qualify if:

• In those with untreated sleep apnea, severe sleepiness with current Epworth Sleepiness Scale (ESS) \> 18 or history of motor vehicle accident due to obstructive sleep apnea
• Taking medications classified as a muscle relaxant
• Pregnant women.
• Psychiatric disorder, other than mild and controlled depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
• Current smokers, alcohol (\>3oz/day) or use of illicit drugs.
• More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
• Unstable cardiac disease (e.g. congestive heart failure)
• Pulmonary disease (apart from well controlled mild asthma and OSA)
• Systemic neuromuscular disease
• Other systemic disease that affects breathing (e.g. stroke) or those with expected survival \< 1 year.
• Poor oral condition, including: active periodontal disease, loose or broken teeth, lack of eight teeth in each arch, active TMJ dysfunction
• Known allergy to oral appliance components

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Atul Malhotra, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 20, 2015
• Study Start: August 1, 2015
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

US (1)