Lifestyle Interventions for Seniors With Apnea
Effects of Weight Loss Through Diet and Exercise on Sleep Apnea Severity and Cardiovascular Risk in Older Adults
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 23, 2011
CompletedFirst Posted
Study publicly available on registry
August 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedAugust 18, 2017
August 1, 2017
1.8 years
August 23, 2011
August 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Vascular Reactivity
Baseline and 3 months
maximal oxygen uptake
Baseline and 3 months
Body composition assessment
Baseline and 3 months
Muscle Strength
Baseline and 3 months
Study Arms (1)
Lifestyle Intervention
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- aged 60-75
- BMI between 30-42
- Apnea-Hypopnea Index above 10 events per hour (verified at baseline testing)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Devon A Dobrosielski, PhD
Johns Hopkins School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2011
First Posted
August 24, 2011
Study Start
October 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
August 18, 2017
Record last verified: 2017-08