ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence of Sleep Apnea in Women

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.
ClinicalTrials.gov Identifier: NCT00005381
Recruitment Status : Active, not recruiting
First Posted : May 26, 2000
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Edward Bixler, Milton S. Hershey Medical Center

Brief Summary:
To identify the prevalence of sleep apnea (SA) in women and its relationship to age; to predict those women at risk for sleep apnea; and to define the natural history of those with sleep apnea.

Condition or disease
Lung Diseases Sleep Apnea Syndromes

Detailed Description:

BACKGROUND:

Often sleep apnea is accompanied by considerable morbidity; the associated excessive daytime sleepiness, cardiovascular abnormalities and cognitive impairment impact greatly on daytime functioning. The obese, hypertensives, elderly and postmenopausal women are reported to be at increased risk for sleep apnea. The investigators published on the prevalence of sleep apnea in several special populations: elderly subjects without sleep complaints and insomniac, narcoleptic, hypertensive and obese patients. They established the prevalence of sleep apnea in men based on the sleep laboratory evaluation of approximately 1,000 men randomly selected from a randomly generated telephone sample of 4,364 men from the general population. Their preliminary estimate of prevalence was that about 2.2 percent of the adult male population have clinically diagnosable sleep apnea. Further, in the male sample, the age distribution was not linearly related to age. Rather, it peaked at approximately age 55. Finally, the major risk factors appeared to be obesity and snoring. The differences in the male/female ratio in clinical and selected populations ranged from 10.0:1 to 1.9:1. One recent study suggested that the prevalence of sleep apnea in women was about two-fold less than in men. However, this study did not sample the general population and used only a restricted age range (30 to 60 years) which did not allow the assessment of the influence of menopause. Thus, the prevalence of sleep apnea in women in the general population remained largely undetermined.

DESIGN NARRATIVE:

In order to establish the prevalence in women with reasonable precision, the prevalence study employed a two-stage sample modified from the prevalence study in men in the following two ways: an expanded telephone sample (N=12,219 women) selected randomly from the general population was evaluated, for clinically relevant risk factors for sleep apnea; and 2) a second sample (N=1,000) selected randomly from the first sample based on higher risk for sleep apnea (including the additional risk factor of menopause) was evaluated in the sleep laboratory to determine the presence of sleep apnea. This strategy yielded an adequate power in order to establish the prevalence of sleep apnea requiring treatment and sleep disordered breathing in women in the general population as well as result in a large enough sample to establish the association between risk factors and sleep apnea in women. In order to perform gender analyses, the study compared previously published data from a total of 4,364 men interviewed in an expanded telephone sample and 741men evaluated in the sleep laboratory.


Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Sleep Apnea in Women
Actual Study Start Date : October 29, 1995
Actual Primary Completion Date : August 2, 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources




Primary Outcome Measures :
  1. Sleep Disordered Breathing [ Time Frame: Immediately upon time of recording ]
    Apnea/hypopnea index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Stratified random sample following initial phone survey
Criteria
Stratified random sample based on risk severity obtained during phone interview

Publications:
Responsible Party: Edward Bixler, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00005381     History of Changes
Other Study ID Numbers: 4286
R01HL051931 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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