AzTrials
AzTrials

Lung DiseasesNCT00005381

Prevalence of Sleep Apnea in Women

An observational study of Lung Diseases and Sleep Apnea Syndromes, run by Milton S. Hershey Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 100 years, women only
Conditions the study is for
Lung Diseases, Sleep Apnea Syndromes
How many people
1,000 participants
Where
No sites listed yet
Study dates
29 Oct 1995to 2 Aug 1998
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Stratified random sample following initial phone survey

Stratified random sample based on risk severity obtained during phone interview

About this study

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.

Read the 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.

Medical subject headings
Lung Diseases, Sleep Apnea Syndromes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep Disordered Breathing

    Apnea/hypopnea index

    Measured: Immediately upon time of recording

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study start29 Oct 1995
  3. Primary completion2 Aug 1998
  4. Study completion2 Aug 1998

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005381
Sponsor's protocol ID
4286
Other IDs
R01HL051931
Status last verified
Apr 2019
First submitted
25 May 2000
Last updated
26 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bixler EO, Vgontzas AN, Lin HM, Ten Have T, Rein J, Vela-Bueno A, Kales A. Prevalence of sleep-disordered breathing in women: effects of gender. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):608-13. doi: 10.1164/ajrccm.163.3.9911064.

    PubMed 11254512

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases and Sleep Apnea Syndromes, run by Milton S. Hershey Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Disordered Breathing (time frame: Immediately upon time of recording). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005381, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in