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Lifestyle Interventions for Seniors With Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring weight loss, exercise, diet, sleep apnea, aging

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle Intervention

Arm Description

Outcomes

Primary Outcome Measures

Polysomnography
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

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

Full Information

First Posted
August 23, 2011
Last Updated
August 15, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01422863
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
weight loss, exercise, diet, sleep apnea, aging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Polysomnography
Description
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
Secondary Outcome Measure Information:
Title
Vascular Reactivity
Description
The Endo-PAT2000 measures endothelium-mediated changes in vascular tone using biosensors that are attached to the fingertips
Time Frame
Baseline and 3 months
Title
maximal oxygen uptake
Description
Testing is done on a treadmill. Participants will be asked to exercise to volitional fatigue
Time Frame
Baseline and 3 months
Title
Body composition assessment
Description
Participants will undergo Dual Energy X-ray Absorptiometry to evaluate total and regional body composition.
Time Frame
Baseline and 3 months
Title
Muscle Strength
Description
Strength testing of the thigh will be done using an isokinetic dynamometer
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devon A Dobrosielski, PhD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Lifestyle Interventions for Seniors With Apnea

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