NCT00860743

Brief Summary

The prevalence of obstructive sleep apnea is high in the Veteran population. If not treated promptly, sleep apnea may result in daytime fatigue which may lead to increased prevalence of accidents while driving or in the workplace. Recent large scale epidemiological studies have shown that the prevalence of excessive daytime sleepiness increases in individuals who suffer from obstructive sleep apnea. Obstructive sleep apnea may also result in the development of hypertension and other cardiovascular disorders. Previous findings have shown that subjects with sleep apnea have a greater risk for developing coronary vascular disease compared to individuals that do not suffer from sleep apnea Thus, a significant amount of evidence suggests that sleep apnea is a major health concern in the Veteran population. Consequently, determining the mechanisms that may impact on the severity of sleep apnea and increase the prevalence of cardiovascular incidents associated with this disorder is important, as is discovering novel treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Sep 2009

Longer than P75 for early_phase_1

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

First Submitted

Initial submission to the registry

March 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 25, 2015

Completed
Last Updated

November 1, 2017

Status Verified

September 1, 2017

Enrollment Period

4 years

First QC Date

March 10, 2009

Results QC Date

December 10, 2014

Last Update Submit

September 29, 2017

Conditions

Sleep Apnea Syndromes

Keywords

intermittent hypoxiaventilatory long-term facilitationautonomic nervous system plasticity

Outcome Measures

Primary Outcomes (2)

  • Ventilation (Aim 1)

    Ventilation was measured before and after exposure to intermittent hypoxia in males and females. Ventilation was measured using a pneumotachograph, which is a flow measuring device.

    Within the same experimental session

  • Heart Rate Variability (Aim 2)

    Heart rate variability (HRV) was measured before and after exposure to intermittent hypoxia following administration of a placebo or antioxidant cocktail. Heart rate variability refers to beat-to-beat alterations in heart rate. Under resting conditions, the electrocardiogram of healthy individuals reveals periodic variation in R-R intervals. To measure HRV, R-R interval data are presented in a graph, in which the y-axis plots the R-R intervals (ms2), and the x-axis the total number of beats. Spectral analysis of the graph transforms the signal from time to frequency on the x-axis (Hz), by representing the signal as a combination of sine and cosine waves, with different amplitudes and frequencies. The approach uses Fourier transforms. The heart rate spectrum contains a high frequency (0.15-0.4 Hz) component, which is synchronous with respiration and a low frequency (0.04 to 0.15 Hz) component that appears to be mediated by both the vagus and cardiac sympathetic nerves.

    Within the same experimental session

Study Arms (2)

Arm 1

NO INTERVENTION

We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.

ANTIOXIDANT COCKTAIL

EXPERIMENTAL

We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.

Drug: Antioxidant cocktail

Interventions

Antioxidant cocktailDRUG

120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.

ANTIOXIDANT COCKTAIL

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Characteristics of OSA subject population:
  • Body mass index \< 30 kg/m2.
  • to 40 years old.
  • Newly diagnosed never-treated mild to moderate sleep apnea (i.e. 50 \> apnea/hypopnea index \>10 events per hour - average nocturnal oxygen saturation \> 90%).
  • Not pregnant.
  • Free of any other known medical conditions.
  • Not taking any medication.
  • Non-smokers with normal lung function.
  • Minimal alcohol consumption (i.e. no more than the equivalent of a glass of wine/day).
  • Characteristics of control group population:
  • Body mass index \< 30 kg/m2.
  • to 40 years old.
  • Apnea/hypopnea index \< 5 events per hour.
  • Not pregnant.
  • Free of any known medical conditions.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John D. Dingell VA Medical Center, Detroit

Detroit, Michigan, 48201, United States

Location

Related Publications (2)

  • Mateika JH, Syed Z. Intermittent hypoxia, respiratory plasticity and sleep apnea in humans: present knowledge and future investigations. Respir Physiol Neurobiol. 2013 Sep 15;188(3):289-300. doi: 10.1016/j.resp.2013.04.010. Epub 2013 Apr 12.

    PMID: 23587570RESULT

  • Syed Z, Lin HS, Mateika JH. The impact of arousal state, sex, and sleep apnea on the magnitude of progressive augmentation and ventilatory long-term facilitation. J Appl Physiol (1985). 2013 Jan 1;114(1):52-65. doi: 10.1152/japplphysiol.00985.2012. Epub 2012 Nov 8.

    PMID: 23139361RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Limitations and Caveats

The primary limitation of this trial was the number of participants that required screening to recruit the participants that met the inclusion criteria for the study. However, once the participants were recruited few withdrew.

Results Point of Contact

Title
Jason H. Mateika
Organization
Wayne State University and John D. Dingell VA Medical Center
jmateika@med.wayne.edu
313-576-4481

Study Officials

  • Jason H Mateika, PhD MS BS

    John D. Dingell VA Medical Center, Detroit

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 12, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 1, 2017

Results First Posted

February 25, 2015

Record last verified: 2017-09

Locations

US(1)