Lung DiseasesNCT00005296
Sleep Apnea: Age Effects On Prevalence and Natural History
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by Milton S. Hershey Medical Center.
Trial summary
To identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk. Read more about this study
- Who is it for?
- Ages 20 to 100 years, men only
- Conditions the study is for
- Lung Diseases, Sleep Apnea Syndromes
- How many people
- 741 participants
- Where
- No sites listed yet
- Study dates
- Jan 1990to 18 Jan 1995
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: stratified random sample following phone interview
stratified random sample based on risk severity for sleep disordered breathing based on phone interview
About this study
To identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk.
Read the detailed description
BACKGROUND:
Sleep apnea is potentially a life-threatening disorder commonly associated with the aging process. Often sleep apnea is accompanied by considerable morbidity for both physical and mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and cognitive impairment impact greatly on daytime functioning. In 1990, the prevalence of sleep apnea in the general population was undetermined, and there was much speculation regarding its natural history.
DESIGN NARRATIVE:
For the prevalence study, 4,364 randomly-sampled men selected from the general population and stratified by age were evaluated for risk factors for sleep apnea. A total of 741 men found to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of sleep apnea or sleep disordered breathing. Prior to recording subjects in the sleep laboratory, a thorough history was obtained from each subject and a physical examination completed. All men entering into the first four years of the prevalence portion of the study who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over a five year period in the natural history part of the study. The natural history portion also included 150 men previously studied in the sleep laboratory for apnea but who were not part of the random sample of 4,000 and who were not part of the prevalence study.
- Conditions
- Lung Diseases, Sleep Apnea Syndromes
- 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.
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.
- First posted26 May 2000 (estimated)
- Study startJan 1990
- Primary completion18 Jan 1995
- Study completion18 Jan 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Edward Bixler, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005296
- Sponsor's protocol ID
- 2019
- Other IDs
- R01HL040916
- 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
Publications
Bixler EO, Vgontzas AN, Ten Have T, Tyson K, Kales A. Effects of age on sleep apnea in men: I. Prevalence and severity. Am J Respir Crit Care Med. 1998 Jan;157(1):144-8. doi: 10.1164/ajrccm.157.1.9706079.
PubMed 9445292
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea: Age Effects On Prevalence and Natural History
- ClinicalTrials.gov ID
- NCT00005296
- Acronym / sponsor ID
- 2019
- Conditions
- Lung Diseases, Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 1990 (actual)
- Primary completion
- 18 Jan 1995 (actual)
- Study completion
- 18 Jan 1995 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk.
Detailed description
BACKGROUND:
Sleep apnea is potentially a life-threatening disorder commonly associated with the aging process. Often sleep apnea is accompanied by considerable morbidity for both physical and mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and cognitive impairment impact greatly on daytime functioning. In 1990, the prevalence of sleep apnea in the general population was undetermined, and there was much speculation regarding its natural history.
DESIGN NARRATIVE:
For the prevalence study, 4,364 randomly-sampled men selected from the general population and stratified by age were evaluated for risk factors for sleep apnea. A total of 741 men found to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of sleep apnea or sleep disordered breathing. Prior to recording subjects in the sleep laboratory, a thorough history was obtained from each subject and a physical examination completed. All men entering into the first four years of the prevalence portion of the study who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over a five year period in the natural history part of the study. The natural history portion also included 150 men previously studied in the sleep laboratory for apnea but who were not part of the random sample of 4,000 and who were not part of the prevalence study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stratified random sample following phone interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sleep disordered breathing
Time frame: immediately upon time of recording
Apnea/hypopnea index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 9445292Bixler EO, Vgontzas AN, Ten Have T, Tyson K, Kales A. Effects of age on sleep apnea in men: I. Prevalence and severity. Am J Respir Crit Care Med. 1998 Jan;157(1):144-8. doi: 10.1164/ajrccm.157.1.9706079.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 NCT00005296, 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; AzTrials last refreshed its copy on 7 Nov 2026.