NCT00834509

Brief Summary

The purpose of the study is to:

  • recruit subjects with untreated sleep apnea; assess overnight changes in their blood and urine chemicals
  • review the overnight changes in blood and urine chemicals after they have been treated for sleep apnea
  • assess the overnight changes in blood and urine chemicals in healthy individuals with no sleep problems
  • compare the amount of fat in the belly using a Magnetic Resonance Imaging (MRI) scanner on all subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

6.8 years

First QC Date

February 2, 2009

Last Update Submit

April 17, 2017

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

  • Magnitude of change in biomarkers during sleep in persons with OSA before & after successful treatment with CPAP, & differences in magnitude of change in persons with different degrees of visceral adiposity, & in those w/ & w/o specific comorbidities.

    End of study

Study Arms (2)

Obstructive Sleep Apnea (OSA)

OSA participants will be treated with a CPAP/APAP treatment, per standard clinical care.

Device: CPAP

Control

Control participants will not receive APAP/CPAP treatment, if not diagnosed with OSA.

Interventions

CPAPDEVICE

Use CPAP for 4-6 weeks as clinically prescribed.

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

OSA patients with moderate to severe disease as confirmed by apnea-hypopnea index (AHI \> 15) in a polysomnography. Healthy controls, both snorers and nonsnorers, with an apnea-hypopnea index (AHI \< 5) in a polysomnography.

You may qualify if:

  • able to read and write in English
  • if female, not pregnant
  • goes to bed between 9:30pm-12:30am and sleeps minimum of 7 hours/night
  • has telephone access
  • BMI \< 40

You may not qualify if:

  • shift worker, irregular schedule
  • previous diagnosis of sleep disorder other than OSA
  • previous treatment with CPAP, BiPAP, oxygen, surgery for OSA
  • current kidney disease, anemia, depression,
  • substance abuse/dependence
  • BMI \> 40
  • visual/hearing/cognitive impairments
  • smoker who's not willing to refrain from all nicotine during study
  • not willing to try CPAP treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Lim DC, Brady DC, Po P, Chuang LP, Marcondes L, Kim EY, Keenan BT, Guo X, Maislin G, Galante RJ, Pack AI. Simulating obstructive sleep apnea patients' oxygenation characteristics into a mouse model of cyclical intermittent hypoxia. J Appl Physiol (1985). 2015 Mar 1;118(5):544-57. doi: 10.1152/japplphysiol.00629.2014. Epub 2014 Nov 26.

    PMID: 25429097DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Primary outcome variables: tumor necrosis factor alpha (TNFα); plasma norepinephrine, and free fatty acids. Secondary biomarkers: Interleukin 6 (IL-6), urinary norepinephrine; urinary normetanephrine; glucose, Intercellular Adhesion Molecule (ICAM), leptin. Monocytes will be separated from each blood sample (before, during and after sleep) and RNA extracted. Expression of key genes will be assessed by RT-PCR and microarray studies will be performed in a subset of subjects to assess changes in expression of all genes as a result of OSA. We will evaluate: a)whether individuals with comorbidities have more oxidative stress and inflammatory change for equivalent degrees of OSA than individuals without such comorbidities; b) whether individuals with comorbidities have lower levels of protective mechanisms-melatonin, IL-10; c) different gene variants based on a genetic association study using a recently developed CV SNP array.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Allan I Pack, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

April 1, 2008

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

US(1)