Sleep DisordersNCT00005557
Epidemiology of Sleep-Disordered Breathing in Adults
An observational study of Sleep Disorders and Cerebrovascular Disorders, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
To characterize the natural history and biologic spectrum of sleep disordered breathing (SDB) and other sleep problems and disorders, and test hypotheses regarding the causes and consequences of SDB and other sleep problems and disorders. Read more about this study
- Who is it for?
- Ages 30 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Cerebrovascular Disorders, Cardiovascular Disease
- How many people
- 1,545 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In 1988, employees of 4 Wisconsin state agencies, ages 30-60 years, were surveyed regarding sleep habits and problems by mail. From these data, a sampling frame was constructed and 2884 randomly-selected men and women (of 4896 survey respondents) were invited to participate in the WSC Study. Recruitment for baseline sleep studies occurred from 1989 to 2004.
Who may be able to join
- Employee of one of the 4 Wisconsin state agencies
- Age 30-60 in 1988
Who cannot join
- Current pregnancy
- Unstable or decompensated cardiopulmonary disease
- Airway cancer
- Recent upper respiratory surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53705
About this study
To characterize the natural history and biologic spectrum of sleep disordered breathing (SDB) and other sleep problems and disorders, and test hypotheses regarding the causes and consequences of SDB and other sleep problems and disorders.
Read the detailed description
BACKGROUND:
Recent research has shown that sleep disordered breathing (SDB) is much more common than previously thought. While it is known that in clinic samples, SDB is associated with hypertension, cardiovascular disease and mortality, little is known about the natural history of this disorder, particularly in the general population, nor about the causal role of known risk factors. The knowledge obtained from the results of this study will help advance the field of sleep disorders medicine. Information about longitudinal effects and causal relationships may be applied to clinical situations, thus reducing the morbidity and mortality associated with this disorder.
DESIGN NARRATIVE:
In this longitudinal study, follow-up polysomnography and other protocols are conducted on an established cohort of men and women (age 30-60 years at the time of initial recruitment in 1989), currently enrolled in the Wisconsin Sleep Cohort Study. The study aims to : 1) describe the natural history of SDB across middle and older age; 2) investigate associations of SDB with early and intermediate markers of cardiovascular dysfunction, damage, and cardiovascular disease; 3) investigate the longitudinal association of SDB in accelerated cognitive decline; 4) investigate the association of SDB and adverse sleep characteristics with age-related risk factors and outcomes.
- Conditions
- Sleep Disorders, Cerebrovascular Disorders, Cardiovascular Disease, Neurologic Disorders, Mood Disorders
- Medical subject headings
- Sleep Wake Disorders, Cerebrovascular Disorders, Cardiovascular Diseases, Nervous System Diseases, Mood Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep disorders and problems, cardiovascular and cognitive outcomes
Overnight polysomnography is used to assess sleep pathology. Questionnaires are used to assess sleep habits. A variety of clinical and laboratory assessments measure cardiovascular and cognitive outcomes.
Measured: measured at each study visit
Secondary outcomes (1)
cardiovascular outcomes
A variety of clinical and laboratory assessments measure cardiovascular outcomes.
Measured: measured at each study visit
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
- Primary completionApr 2028 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- 1,545 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Paul E Peppard, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005557
- Sponsor's protocol ID
- 2012-0084
- Other IDs
- R01HL062252, A538500, SMPH/POP HEALTH SCI/POP HLTH
- Status last verified
- Oct 2026
- First submitted
- 25 May 2000
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
PubMed 10805822Peppard PE, Young T, Palta M, Dempsey J, Skatrud J. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA. 2000 Dec 20;284(23):3015-21. doi: 10.1001/jama.284.23.3015.
PubMed 11122588Young T, Finn L, Palta M. Chronic nasal congestion at night is a risk factor for snoring in a population-based cohort study. Arch Intern Med. 2001 Jun 25;161(12):1514-9. doi: 10.1001/archinte.161.12.1514.
PubMed 11427099Kadotani H, Kadotani T, Young T, Peppard PE, Finn L, Colrain IM, Murphy GM Jr, Mignot E. Association between apolipoprotein E epsilon4 and sleep-disordered breathing in adults. JAMA. 2001 Jun 13;285(22):2888-90. doi: 10.1001/jama.285.22.2888.
PubMed 11401610Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
PubMed 11991871Punjabi NM, Bandeen-Roche K, Young T. Predictors of objective sleep tendency in the general population. Sleep. 2003 Sep;26(6):678-83. doi: 10.1093/sleep/26.6.678.
PubMed 14572120Young T, Rabago D, Zgierska A, Austin D, Laurel F. Objective and subjective sleep quality in premenopausal, perimenopausal, and postmenopausal women in the Wisconsin Sleep Cohort Study. Sleep. 2003 Sep;26(6):667-72. doi: 10.1093/sleep/26.6.667.
PubMed 14572118Lin L, Finn L, Zhang J, Young T, Mignot E. Angiotensin-converting enzyme, sleep-disordered breathing, and hypertension. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1349-53. doi: 10.1164/rccm.200405-616OC. Epub 2004 Sep 24.
PubMed 15447944Peppard PE, Young T. Exercise and sleep-disordered breathing: an association independent of body habitus. Sleep. 2004 May 1;27(3):480-4. doi: 10.1093/sleep/27.3.480.
PubMed 15164902Reichmuth KJ, Austin D, Skatrud JB, Young T. Association of sleep apnea and type II diabetes: a population-based study. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1590-5. doi: 10.1164/rccm.200504-637OC. Epub 2005 Sep 28.
PubMed 16192452Arzt M, Young T, Finn L, Skatrud JB, Bradley TD. Association of sleep-disordered breathing and the occurrence of stroke. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1447-51. doi: 10.1164/rccm.200505-702OC. Epub 2005 Sep 1.
PubMed 16141444Kuo WC, Bratzke LC, Hagen EW, Hale L, Brown RL, Barnet JH, Peppard PE. Metabolic health disparities driven by financial stress: Behavioural adaptation or modification? Stress Health. 2023 Aug;39(3):614-626. doi: 10.1002/smi.3210. Epub 2022 Dec 1.
PubMed 36413205Kuo WC, Ersig AL, Johnson HM, Brown RL, Oakley LD, Hagen EW, Barnet JH, Peppard PE. Association between stressful life events and non-optimal lipid levels among women with hyperlipidaemia. Eur J Cardiovasc Nurs. 2023 Mar 1;22(2):210-219. doi: 10.1093/eurjcn/zvac032.
PubMed 35714051Kuo WC, Oakley LD, Brown RL, Hagen EW, Barnet JH, Peppard PE, Bratzke LC. Gender Differences in the Relationship Between Financial Stress and Metabolic Abnormalities. Nurs Res. 2021 Mar-Apr 01;70(2):123-131. doi: 10.1097/NNR.0000000000000489.
PubMed 33630535
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Sleep-Disordered Breathing in Adults
- ClinicalTrials.gov ID
- NCT00005557
- Acronym / sponsor ID
- 2012-0084
- Conditions
- Sleep Disorders, Cerebrovascular Disorders, Cardiovascular Disease, Neurologic Disorders, Mood Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,545 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1999
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2031 (estimated)
- 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 characterize the natural history and biologic spectrum of sleep disordered breathing (SDB) and other sleep problems and disorders, and test hypotheses regarding the causes and consequences of SDB and other sleep problems and disorders.
Detailed description
BACKGROUND:
Recent research has shown that sleep disordered breathing (SDB) is much more common than previously thought. While it is known that in clinic samples, SDB is associated with hypertension, cardiovascular disease and mortality, little is known about the natural history of this disorder, particularly in the general population, nor about the causal role of known risk factors. The knowledge obtained from the results of this study will help advance the field of sleep disorders medicine. Information about longitudinal effects and causal relationships may be applied to clinical situations, thus reducing the morbidity and mortality associated with this disorder.
DESIGN NARRATIVE:
In this longitudinal study, follow-up polysomnography and other protocols are conducted on an established cohort of men and women (age 30-60 years at the time of initial recruitment in 1989), currently enrolled in the Wisconsin Sleep Cohort Study. The study aims to : 1) describe the natural history of SDB across middle and older age; 2) investigate associations of SDB with early and intermediate markers of cardiovascular dysfunction, damage, and cardiovascular disease; 3) investigate the longitudinal association of SDB in accelerated cognitive decline; 4) investigate the association of SDB and adverse sleep characteristics with age-related risk factors and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In 1988, employees of 4 Wisconsin state agencies, ages 30-60 years, were surveyed regarding sleep habits and problems by mail. From these data, a sampling frame was constructed and 2884 randomly-selected men and women (of 4896 survey respondents) were invited to participate in the WSC Study. Recruitment for baseline sleep studies occurred from 1989 to 2004.
Key inclusion criteria (2 listed)
- Employee of one of the 4 Wisconsin state agencies
- Age 30-60 in 1988
Key exclusion criteria (4 listed)
- Current pregnancy
- Unstable or decompensated cardiopulmonary disease
- Airway cancer
- Recent upper respiratory surgery
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 disorders and problems, cardiovascular and cognitive outcomes
Time frame: measured at each study visit
Overnight polysomnography is used to assess sleep pathology. Questionnaires are used to assess sleep habits. A variety of clinical and laboratory assessments measure cardiovascular and cognitive outcomes.
1 secondary outcome
cardiovascular outcomes
Time frame: measured at each study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 10805822Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
- Background: PubMed 11122588Peppard PE, Young T, Palta M, Dempsey J, Skatrud J. Longitudinal study of moderate weight change and sleep-disordered breathing. JAMA. 2000 Dec 20;284(23):3015-21. doi: 10.1001/jama.284.23.3015.
- Background: PubMed 11427099Young T, Finn L, Palta M. Chronic nasal congestion at night is a risk factor for snoring in a population-based cohort study. Arch Intern Med. 2001 Jun 25;161(12):1514-9. doi: 10.1001/archinte.161.12.1514.
- Background: PubMed 11401610Kadotani H, Kadotani T, Young T, Peppard PE, Finn L, Colrain IM, Murphy GM Jr, Mignot E. Association between apolipoprotein E epsilon4 and sleep-disordered breathing in adults. JAMA. 2001 Jun 13;285(22):2888-90. doi: 10.1001/jama.285.22.2888.
- Background: PubMed 11991871Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.
- Background: PubMed 14572120Punjabi NM, Bandeen-Roche K, Young T. Predictors of objective sleep tendency in the general population. Sleep. 2003 Sep;26(6):678-83. doi: 10.1093/sleep/26.6.678.
- Background: PubMed 14572118Young T, Rabago D, Zgierska A, Austin D, Laurel F. Objective and subjective sleep quality in premenopausal, perimenopausal, and postmenopausal women in the Wisconsin Sleep Cohort Study. Sleep. 2003 Sep;26(6):667-72. doi: 10.1093/sleep/26.6.667.
- Background: PubMed 15447944Lin L, Finn L, Zhang J, Young T, Mignot E. Angiotensin-converting enzyme, sleep-disordered breathing, and hypertension. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1349-53. doi: 10.1164/rccm.200405-616OC. Epub 2004 Sep 24.
- Background: PubMed 15164902Peppard PE, Young T. Exercise and sleep-disordered breathing: an association independent of body habitus. Sleep. 2004 May 1;27(3):480-4. doi: 10.1093/sleep/27.3.480.
- Background: PubMed 16192452Reichmuth KJ, Austin D, Skatrud JB, Young T. Association of sleep apnea and type II diabetes: a population-based study. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1590-5. doi: 10.1164/rccm.200504-637OC. Epub 2005 Sep 28.
- Background: PubMed 16141444Arzt M, Young T, Finn L, Skatrud JB, Bradley TD. Association of sleep-disordered breathing and the occurrence of stroke. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1447-51. doi: 10.1164/rccm.200505-702OC. Epub 2005 Sep 1.
- Derived from this study: PubMed 36413205Kuo WC, Bratzke LC, Hagen EW, Hale L, Brown RL, Barnet JH, Peppard PE. Metabolic health disparities driven by financial stress: Behavioural adaptation or modification? Stress Health. 2023 Aug;39(3):614-626. doi: 10.1002/smi.3210. Epub 2022 Dec 1.
- Individual participant dataSharing planned: Undecided
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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.
Paul E Peppard, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders and Cerebrovascular Disorders, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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 disorders and problems, cardiovascular and cognitive outcomes (time frame: measured at each study visit). 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 NCT00005557, which also lists 14 linked publications.
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 Oct 2026.