Lifestyle Interventions for Seniors With Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01422863
Recruitment Status : Completed
First Posted : August 24, 2011
Last Update Posted : August 18, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Behavioral: Lifestyle Intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Weight Loss Through Diet and Exercise on Sleep Apnea Severity and Cardiovascular Risk in Older Adults
Study Start Date : October 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lifestyle 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.

Primary Outcome Measures :
  1. Polysomnography [ Time Frame: 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 :
  1. Vascular Reactivity [ Time Frame: Baseline and 3 months ]
    The Endo-PAT2000 measures endothelium-mediated changes in vascular tone using biosensors that are attached to the fingertips

  2. maximal oxygen uptake [ Time Frame: Baseline and 3 months ]
    Testing is done on a treadmill. Participants will be asked to exercise to volitional fatigue

  3. Body composition assessment [ Time Frame: Baseline and 3 months ]
    Participants will undergo Dual Energy X-ray Absorptiometry to evaluate total and regional body composition.

  4. Muscle Strength [ Time Frame: Baseline and 3 months ]
    Strength testing of the thigh will be done using an isokinetic dynamometer

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01422863

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Devon A Dobrosielski, PhD Johns Hopkins School of Medicine

Responsible Party: Johns Hopkins University Identifier: NCT01422863     History of Changes
Other Study ID Numbers: LIZA
First Posted: August 24, 2011    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by Johns Hopkins University:
weight loss
sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases