Sleep Apnea Clinical Trial
Official title:
Determinants of Age-specific Breathing Instability During Sleep
Verified date | October 2015 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose for our research protocol is to examine the role of breathing control mechanisms that determine the development of sleep-disordered breathing in the elderly. This proposal will focus on key factors that contribute to the control of ventilation in healthy individuals and in subjects with sleep-disordered breathing. We will study the age-specific changes in both normal persons and sleep individuals with sleep apnea.
Status | Completed |
Enrollment | 92 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Normal subjects without sleep apnea (controls) and individuals with sleep apnea. Exclusion Criteria: - Pregnancy, - history of active coronary artery disease-including stable and unstable angina, - myocardial infarction, - history of congestive heart failure, - stroke, who have excessive daytime sleepiness with Epworth Sleepiness Scale of >15 will not be included in the study - patient with OSA who - depression, - schizophrenia, - untreated hypothyroidism, - diabetes on insulin, - seizure disorder, - intrinsic renal and liver disorders, - failure to give informed consent, - patients with evidence of pulmonary diseases based on history and abnormal pulmonary function testing, including obstructive (ratio of predicted forced expiratory volume to forced vital capacity, <80% predicted) or restrictive lung disorders (total lung capacity <80% predicted) with resting oxygen saturation of <96% and kyphoscoliosis (chest wall deformities) will be excluded, - patients on certain medications including, opiates derivatives, stimulants, antidepressants, tranquilizers, anti-psychotic agents, theophylline and other central nervous system altering medications will be ineligible, - history of alcohol or recreational drug use will also serve as grounds for exclusion, - patients with body mass index (BMI) >34kg/m2 will be excluded, - subjects with sleep apnea are already using continuous positive airway pressure for more than 7 days as therapy will not be eligible. |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | John D. Dingell VA Medical Center, Detroit, MI | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Apneic threshold | 4-6 wks for each participant | No | |
Secondary | Long-term facilitation | 4-6 wks for each participant | No | |
Secondary | Upper airway resistance | 4-6 wks for each participant | No |
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