Lifestyle Interventions for Seniors With Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT01422863
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Lifestyle Intervention	-

Primary Outcome Measures

Name	Time	Method
Polysomnography	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 Outcome Measures

Name	Time	Method
maximal oxygen uptake	Baseline and 3 months	Testing is done on a treadmill. Participants will be asked to exercise to volitional fatigue
Muscle Strength	Baseline and 3 months	Strength testing of the thigh will be done using an isokinetic dynamometer
Vascular Reactivity	Baseline and 3 months	The Endo-PAT2000 measures endothelium-mediated changes in vascular tone using biosensors that are attached to the fingertips
Body composition assessment	Baseline and 3 months	Participants will undergo Dual Energy X-ray Absorptiometry to evaluate total and regional body composition.

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States