An interventional study of Lifestyle Intervention in Obstructive Sleep Apnea, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 60 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-18.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
The overall goal of this study is to determine the efficacy of a lifestyle intervention, consisting of a weight loss diet and exercise on sleep apnea in older adults. The investigators will conduct a 3-month intervention in men and women who are sedentary with suspected sleep apnea. The investigators hypothesize that the intervention will lead to marked improvements in sleep apnea severity and cardiovascular risk markers.
Frailty, a condition characterized by a decrease in physiological reserve and increased risk for adverse health-related outcomes, is an increased risk of aging, especially in the presence of co-morbid conditions. Sleep apnea is also highly prevalent with increasing age. Both conditions share common pathologies, suggesting that sleep apnea may increase the risk of developing or exacerbate the consequences of frailty. Lifestyle interventions as strategies for treating sleep apnea and associated co-morbidities, thereby highlighting a feasible approach by which to reduce the incidence or progression of frailty. The specific aims of this study are to: 1) determine the effectiveness of a lifestyle intervention (LI), consisting of a weight loss diet and supervised exercise, on reducing sleep apnea in older adults, and 2) determine whether this intervention is effective at improving parameters that are common to both sleep apnea and frailty, such as poor physical functional capacity and body composition, impaired or abnormal cardiometabolic function and increased levels of inflammation.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
Behavioral: Lifestyle Intervention
Participants undergo 3 months of monitored exercise, consisting of aerobic and resistance training (3 days per week for 1 hour). Participants will also meet with a registered dietician, who will prescribe an American Heart Association low fat diet. The goal is to achieve a 1-2 lb weight loss per week.
Polysomnography
Overnight Polysomnography will be used to measure Apnea-hypopnea index (AHI)- The number of arousals occurring over the course of the night
Time frame: Baseline and 3 months
Vascular Reactivity
The Endo-PAT2000 measures endothelium-mediated changes in vascular tone using biosensors that are attached to the fingertips
Time frame: Baseline and 3 months
maximal oxygen uptake
Testing is done on a treadmill. Participants will be asked to exercise to volitional fatigue
Time frame: Baseline and 3 months
Body composition assessment
Participants will undergo Dual Energy X-ray Absorptiometry to evaluate total and regional body composition.
Time frame: Baseline and 3 months
Muscle Strength
Strength testing of the thigh will be done using an isokinetic dynamometer
Time frame: Baseline and 3 months
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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