NCT00070681

Brief Summary

To determine the effects of sleep disorders on cardiovascular function and disease in older men.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2003

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 29, 2016

Status Verified

April 1, 2009

Enrollment Period

3.8 years

First QC Date

October 6, 2003

Last Update Submit

July 28, 2016

Conditions

Cardiovascular DiseasesHeart DiseasesSleepSleep Apnea SyndromesNeurologic ManifestationsOsteoporosisBone Diseases

Interventions

PolysomnographyPROCEDURE

Eligibility Criteria

Age65 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (4)

  • Hartmann S, Parrino L, Ensrud K, Stone KL, Redline S, Clark SR, Baumert M. Association between psychotropic medication and sleep microstructure: evidence from large population studies. J Clin Sleep Med. 2023 Mar 1;19(3):581-589. doi: 10.5664/jcsm.10394.

    PMID: 36546402DERIVED

  • Shahrbabaki SS, Linz D, Redline S, Stone K, Ensrud K, Baumert M. Sleep Arousal-Related Ventricular Repolarization Lability Is Associated With Cardiovascular Mortality in Older Community-Dwelling Men. Chest. 2023 Feb;163(2):419-432. doi: 10.1016/j.chest.2022.09.043. Epub 2022 Oct 13.

    PMID: 36244405DERIVED

  • May AM, May RD, Bena J, Wang L, Monahan K, Stone KL, Barrett-Connor E, Koo BB, Winkelman JW, Redline S, Mittleman MA, Mehra R; Osteoporotic Fractures in Men (MrOS) Study Group. Individual periodic limb movements with arousal are temporally associated with nonsustained ventricular tachycardia: a case-crossover analysis. Sleep. 2019 Oct 21;42(11):zsz165. doi: 10.1093/sleep/zsz165.

    PMID: 31585012DERIVED

  • Baumert M, Immanuel SA, Stone KL, Litwack Harrison S, Redline S, Mariani S, Sanders P, McEvoy RD, Linz D. Composition of nocturnal hypoxaemic burden and its prognostic value for cardiovascular mortality in older community-dwelling men. Eur Heart J. 2020 Jan 21;41(4):533-541. doi: 10.1093/eurheartj/ehy838.

    PMID: 30590586DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesSleep Apnea SyndromesNeurologic ManifestationsOsteoporosisBone Diseases

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBone Diseases, MetabolicMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Elizabeth Barrett-Connor

    University of California, San Diego

  • Jane Cauley

    University of Pittsburgh

  • Kristine Ensrud

    University of Minnesota

  • Cora Lewis

    University of Alabama at Birmingham

  • Eric Orwoll

    Oregon Health and Science University

  • Susan Redline

    Case Western Reserve University

  • Marcia Stefanick

    Stanford University

  • Katie Stone

    University of California, San Francisco

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

October 6, 2003

First Posted

October 9, 2003

Study Start

September 1, 2003

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

July 29, 2016

Record last verified: 2009-04