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Clinical Trials/NCT01422863
NCT01422863
Completed
N/A

Effects of Weight Loss Through Diet and Exercise on Sleep Apnea Severity and Cardiovascular Risk in Older Adults

Johns Hopkins University1 site in 1 country18 target enrollmentOctober 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Johns Hopkins University
Enrollment
18
Locations
1
Primary Endpoint
Polysomnography
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
July 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • aged 60-75
  • BMI between 30-42
  • Apnea-Hypopnea Index above 10 events per hour (verified at baseline testing)

Exclusion Criteria

  • currently following a weight loss diet
  • history of substance abuse
  • participating in moderate to vigorous activity most days of the week
  • history of cardiovascular disease
  • currently being treated for sleep apnea
  • current cigarette smoking

Outcomes

Primary Outcomes

Polysomnography

Time Frame: Baseline and 3 months

Overnight Polysomnography will be used to measure Apnea-hypopnea index (AHI)- The number of arousals occurring over the course of the night

Secondary Outcomes

  • Muscle Strength(Baseline and 3 months)
  • maximal oxygen uptake(Baseline and 3 months)
  • Vascular Reactivity(Baseline and 3 months)
  • Body composition assessment(Baseline and 3 months)

Study Sites (1)

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