Lung DiseasesNCT00005551
Sleep Apnea in a Non-Clinical Population
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the causes, consequences and quantitation of sleep disordered breathing (SDB). Read more about this study
- Who is it for?
- Ages 30 to 60 years, men only
- Conditions the study is for
- Lung Diseases, Sleep Apnea Syndromes, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1999to Mar 2002
- 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 30 to 60 years
- Men only
- No healthy volunteers
- Adult
No eligibility criteria
About this study
To investigate the causes, consequences and quantitation of sleep disordered breathing (SDB).
Read the detailed description
BACKGROUND:
The study utilized an extremely rich source of data collected on the Wisconsin Sleep Cohort, one of the largest cohort studies of SDB and one with the longest periods of follow-up, to address a broad array of questions related to the pathogenesis and risk of SDB in the general community. The data-set was obtained between 1988 and 1998 in a population of 1400 workers age 30 to 60 years, including an overnight sleep polysomnographic in-lab study conducted on two occasions over an eight year period. The dataset contained a computerized analysis of over 300,000 apneas and hypopneas in this non-clinical population.
Although strong associations have been demonstrated between sleep disordered breathing and cardiovascular diseases, much is not known regarding the mechanisms by which SDB produces blood pressure changes and increases morbidity. Further analysis of the polysomnography and blood pressure data could yield important insights into the physiologic events responsible for cardiovascular morbidity. Such information could then be used to develop diagnostic tests that identify those people at highest risk and thus who might especially benefit from intervention. This would be of potentially great public health importance, given the prevalence of SDB and the availability of treatments for SDB.
DESIGN NARRATIVE:
The investigators used the computerized database of the Wisconsin Sleep Cohort to answer the following specific questions. What were the physiologic characteristics of SDB events in the non-clinical population in terms of severity, high airway resistance, obstructive and central components and associated after-effects on EEG arousal and ventilatory overshoots? Did these important elements of the SDB event change as SDB progressed over time? Did the ventilatory or cardiovascular consequences of apnea or hypopnea and its immediate aftermath determine the likelihood of subsequent sleep-disordered breathing events? 2. What were the immediate and long-term cardiovascular consequences of sleep-disordered breathing events; what characteristics of these SDB events (such as oxygen desaturation, arousal, ventilatory overshoot airway resistance, etc.) determined the cardiovascular responses and consequences? 3. What was the effect of aging on SDB and its sequelae as studied in the truly healthy elderly? 4. What role did anatomical characteristics of the upper airway play in determining the frequency and severity and type of sleep-disordered breathing? Did these anatomical determinants differ in the general non-clinical population versus the obstructive sleep apnea (OSA) population? ... in the obese versus the non-obese?
Organization responded that the study is non-FDAAA applicable and they do not accept transfer to their organization.
- Conditions
- Lung Diseases, Sleep Apnea Syndromes, Obesity, Cardiovascular Diseases, Heart Diseases, Hypertension
- Medical subject headings
- Lung Diseases, Sleep Apnea Syndromes, Obesity, Cardiovascular Diseases, Heart Diseases, Hypertension
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 startApr 1999
- Study completionMar 2002
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 National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Jerome Dempsey, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005551
- Sponsor's protocol ID
- 5095
- Other IDs
- R03HL062686
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Dempsey JA, Skatrud JB, Jacques AJ, Ewanowski SJ, Woodson BT, Hanson PR, Goodman B. Anatomic determinants of sleep-disordered breathing across the spectrum of clinical and nonclinical male subjects. Chest. 2002 Sep;122(3):840-51. doi: 10.1378/chest.122.3.840.
PubMed 12226022
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea in a Non-Clinical Population
- ClinicalTrials.gov ID
- NCT00005551
- Acronym / sponsor ID
- 5095
- Conditions
- Lung Diseases, Sleep Apnea Syndromes, Obesity, Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1999
- Study completion
- Mar 2002 (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 investigate the causes, consequences and quantitation of sleep disordered breathing (SDB).
Detailed description
BACKGROUND:
The study utilized an extremely rich source of data collected on the Wisconsin Sleep Cohort, one of the largest cohort studies of SDB and one with the longest periods of follow-up, to address a broad array of questions related to the pathogenesis and risk of SDB in the general community. The data-set was obtained between 1988 and 1998 in a population of 1400 workers age 30 to 60 years, including an overnight sleep polysomnographic in-lab study conducted on two occasions over an eight year period. The dataset contained a computerized analysis of over 300,000 apneas and hypopneas in this non-clinical population.
Although strong associations have been demonstrated between sleep disordered breathing and cardiovascular diseases, much is not known regarding the mechanisms by which SDB produces blood pressure changes and increases morbidity. Further analysis of the polysomnography and blood pressure data could yield important insights into the physiologic events responsible for cardiovascular morbidity. Such information could then be used to develop diagnostic tests that identify those people at highest risk and thus who might especially benefit from intervention. This would be of potentially great public health importance, given the prevalence of SDB and the availability of treatments for SDB.
DESIGN NARRATIVE:
The investigators used the computerized database of the Wisconsin Sleep Cohort to answer the following specific questions. What were the physiologic characteristics of SDB events in the non-clinical population in terms of severity, high airway resistance, obstructive and central components and associated after-effects on EEG arousal and ventilatory overshoots? Did these important elements of the SDB event change as SDB progressed over time? Did the ventilatory or cardiovascular consequences of apnea or hypopnea and its immediate aftermath determine the likelihood of subsequent sleep-disordered breathing events? 2. What were the immediate and long-term cardiovascular consequences of sleep-disordered breathing events; what characteristics of these SDB events (such as oxygen desaturation, arousal, ventilatory overshoot airway resistance, etc.) determined the cardiovascular responses and consequences? 3. What was the effect of aging on SDB and its sequelae as studied in the truly healthy elderly? 4. What role did anatomical characteristics of the upper airway play in determining the frequency and severity and type of sleep-disordered breathing? Did these anatomical determinants differ in the general non-clinical population versus the obstructive sleep apnea (OSA) population? ... in the obese versus the non-obese?
Organization responded that the study is non-FDAAA applicable and they do not accept transfer to their organization.
Study design
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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
Not reported in the source record.
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 13 May 2016.
- Background: PubMed 12226022Dempsey JA, Skatrud JB, Jacques AJ, Ewanowski SJ, Woodson BT, Hanson PR, Goodman B. Anatomic determinants of sleep-disordered breathing across the spectrum of clinical and nonclinical male subjects. Chest. 2002 Sep;122(3):840-51. doi: 10.1378/chest.122.3.840.
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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.
Jerome Dempsey
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Sleep Apnea Syndromes, run by National Heart, Lung, and Blood Institute (NHLBI).
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 13 May 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005551, 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 13 May 2016.