Clinical trial NCT01422863: Lifestyle Interventions for Seniors With Apnea
Official title: Effects of Weight Loss Through Diet and Exercise on Sleep Apnea Severity and Cardiovascular Risk in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: weight loss
exercise
diet
sleep apnea
aging
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2011-08-24
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Polysomnography
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Vascular Reactivity
timeFrame: Baseline and 3 months
measure: maximal oxygen uptake
timeFrame: Baseline and 3 months
measure: Body composition assessment
timeFrame: Baseline and 3 months
measure: Muscle Strength
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Devon A Dobrosielski, PhD
role: PRINCIPAL_INVESTIGATOR
References: