NCT00177892

Brief Summary

The purpose of this study is to define the mechanism(s) through which Obstructive Sleep Apnea/Hypopnea (OSAH) promotes abnormal metabolic processes which characterize the metabolic syndrome. The investigators hypothesize that the sleep fragmentation and intermittent sleep hypoxia which occur in OSAH patients promote oxidative stress and inflammation which in turn lead to insulin resistance, dyslipidemia, abnormal vascular reactivity and other processes which are consistent with the metabolic syndrome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

March 3, 2008

Status Verified

February 1, 2008

Enrollment Period

4.9 years

First QC Date

September 13, 2005

Last Update Submit

February 28, 2008

Conditions

Obstructive Sleep ApneaMetabolic Syndrome X

Keywords

Sleep fragmentationIntermittent hypoxiaObstructive Sleep ApneaMetabolic SyndromeInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • circulating and exhaled biomarkers of oxidative stress and pro-inflammatory cytokines, insulin resistance, lipid profile, plasma cortisol, and heart period variability (a reflection of sympathovagal tone)

    before and after 2 consecutive nights

Study Arms (5)

1

EXPERIMENTAL

non-OSAH/overweight individuals with the Metabolic Syndrome

Procedure: sleep disruption

2

EXPERIMENTAL

non-OSAH/overweight individuals without Metabolic Syndrome

Procedure: sleep disruption

3

ACTIVE COMPARATOR

non-OSAH/normal weight without Metabolic Syndrome

Procedure: sleep disruption

4

EXPERIMENTAL

OSAH patients with chronic positive airway pressure therapy

Procedure: sleep with and without positive pressure

5

EXPERIMENTAL

OSAH patients without chronic positive airway pressure therapy

Procedure: sleep with and without positive pressure

Interventions

sleep disruptionPROCEDURE

experimentally-induced Sleep Fragmentation

123
sleep with and without positive pressurePROCEDURE

OSAH patients with and without chronic positive airway pressure therapy

Also known as: fragmentation + normoxia, fragmentation + hypoxia
45

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nonsmoker for at least 6 months
  • No history of movement disorder during sleep, or circadian rhythm disorder
  • No excessive daytime sleepiness
  • No history of chronic insomnia, mood or affective disorders or other psychiatric disorders
  • Participants maintain a regular sleep-wake pattern with an estimated sleep time between 6.5 and 10 hours per night
  • Ability and willingness to avoid meat with its juice (gravy), cured or smoked foods and green leafy vegetables, fruit and fruit juices, food products or vitamin supplements containing vitamin C and E supplements for at least 1 day prior to and during the study periods
  • Consumption of less than 1 alcoholic beverage per day
  • Ability to understand the study and sign the informed consent
  • Not currently pregnant
  • Live within 45 miles of the study site
  • No uncontrolled hypertension (blood pressure greater than 150/100)
  • Willingness to avoid caffeinated beverages and food during the study protocol period
  • Participants With Sleep Apnea:
  • Diagnosis of severe Obstructive Sleep Apnea and Hypopnea (OSAH) (RDI greater than 25) and initiation of positive airway pressure therapy more than 1 month before enrollment
  • Must have had an adequate clinical titration of positive airway pressure therapy
  • +2 more criteria

You may not qualify if:

  • History or physical examination evidence of active coronary artery disease, heart failure, cardiomyopathy, syncope, potentially life-threatening arrhythmia, stroke, transient ischemic attack, neurologic impairment, renal, hepatic or thyroid disease (unless on stable thyroid replacement medication); history of diabetes mellitus; history of cancer within the past 10 years (other than basal cell carcinoma), venous thrombosis, or collagen-vascular disease or other condition that the investigators believe may be exacerbated by participation in the stud
  • History of awakening with angina pectoris
  • Currently taking medication for mood or affective disorders or that affect heme metabolism, autonomic nervous system or sleep architecture, or prescribed nitrates or corticosteroids
  • Physician-diagnosed Alzheimer's or non-Alzheimer's dementia
  • Previous surgery for sleep apnea
  • Hematocrit less than 32
  • Use of a hearing aid in one or both ears
  • History of a bleeding disorder, abnormal bleeding, or known adverse reaction to heparin
  • Inability to obtain venous blood or a low likelihood of obtaining venous access as required in this protocol
  • History of migraine of a nature, frequency, and severity that, in the investigators' judgement, may be precipitated by participation in the protocol
  • Presence of a potentially life-threatening dysrhythmia on the clinical diagnostic PSG
  • History of motor vehicle accident due to falling asleep; not currently employed as a driver in the transportation industry or an airplane pilot
  • Lipid-lowering agents for participants without a history of sleep apnea
  • Individuals on positive airway pressure therapy for sleep apnea must not have lost more than 10 pounds of weight since starting this treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveMetabolic SyndromeSleep DeprivationInsulin Resistance

Interventions

Sleep

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mark H Sanders, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynnette Robinson, BS

CONTACT

412-647-1345robinsonlm@upmc.edu

Mark H Sanders, MD

CONTACT

412-692-2880sandersmh@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

September 1, 2003

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

March 3, 2008

Record last verified: 2008-02

Locations

US(1)