Lifestyle Interventions for Seniors With Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422863
• Other study ID #: LIZA
• Status: Completed
• Phase: N/A
• First received: August 23, 2011
• Last updated: August 15, 2017
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography	Overnight Polysomnography will be used to measure Apnea-hypopnea index (AHI)- The number of arousals occurring over the course of the night	Baseline and 3 months
Secondary	Vascular Reactivity	The Endo-PAT2000 measures endothelium-mediated changes in vascular tone using biosensors that are attached to the fingertips	Baseline and 3 months
Secondary	maximal oxygen uptake	Testing is done on a treadmill. Participants will be asked to exercise to volitional fatigue	Baseline and 3 months
Secondary	Body composition assessment	Participants will undergo Dual Energy X-ray Absorptiometry to evaluate total and regional body composition.	Baseline and 3 months
Secondary	Muscle Strength	Strength testing of the thigh will be done using an isokinetic dynamometer	Baseline and 3 months