Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
B Tucker Woodson, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01196117
First received: September 3, 2010
Last updated: April 8, 2014
Last verified: April 2014

September 3, 2010
April 8, 2014
November 2004
December 2011   (final data collection date for primary outcome measure)
Salivary Cortisol Level [ Time Frame: throughout the patient's 28 day participation ] [ Designated as safety issue: No ]
Salivary Cortisol Level in relation to Placebo and continuous positive airway pressure (CPAP) use
Salivary Cortisol Level [ Time Frame: throughout the patient's 28 day participation ] [ Designated as safety issue: No ]
Salivary Cortisol Level in relation to Placebo and CPAP use
Complete list of historical versions of study NCT01196117 on ClinicalTrials.gov Archive Site
Epworth Sleepiness Score (ESS) [ Time Frame: throughout the patient's 28 day participation ] [ Designated as safety issue: No ]
Epworth Sleepiness Score in relation to Placebo and continuous positive airway pressure (CPAP) use
Epworth Sleepiness Score (ESS) [ Time Frame: throughout the patient's 28 day participation ] [ Designated as safety issue: No ]
Epworth Sleepiness Score in relation to Placebo and CPAP use
Not Provided
Not Provided
 
Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea

Patients with Obstructive Sleep Apnea Syndrome (OSAS) will evidence higher levels of salivary cortisol and alpha-amylase levels prior to use of placebo and continuous positive airway pressure (CPAP) and will evidence a decrease in these levels after consistent use of continuous positive airway pressure (CPAP) therapy as compared to placebo. Their level of sleepiness will also decrease with the use of CPAP therapy and will correlate with the levels of salivary cortisol and alpha-amylase in relation to their subjective sleepiness scale, Psychomotor Vigilance Test (PVT), and pupillometry.

It has been shown that there is an inconsistent response in serum cortisol levels in patients with Obstructive Sleep Apnea Syndrome (OSAS), but it is undetermined whether a change in hormone level was not seen due to compliance issues in these long-term studies. These investigators will be employing compliance monitoring continuous positive airway pressure (CPAP) machines and also assessing "sleepiness" before and after therapy. Sleepiness is the dependent variable in our study and will be measured subjectively using sleepiness scales and objectively using Psychomotor Vigilance Test (PVT) and an autonomic measure using pupillometry prior, during and after treatment.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Sleep Apnea
  • Sleep Disordered Breathing
  • Device: 14 days of CPAP therapy
    14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
    Other Name: CPAP arm
  • Device: 14 days of placebo therapy
    14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
    Other Name: placebo arm, non-CPAP arm
  • Active Comparator: 14 days of CPAP therapy
    14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
    Intervention: Device: 14 days of CPAP therapy
  • Placebo Comparator: 14 days of Placebo therapy
    14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
    Intervention: Device: 14 days of placebo therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults
  • Male and female
  • Between ages 18 and 90
  • Undergo a Polysomnography (PSG) with evidence of any sleep disordered breathing including snoring, mild/moderate/severe sleep apnea, and/or restless legs

Exclusion Criteria:

  • Ages 17 and under
  • Pregnant women
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01196117
481-04
No
B Tucker Woodson, Medical College of Wisconsin
Medical College of Wisconsin
ResMed
Study Chair: Hersel Raff, PhD Medical College of Wisconsin
Study Chair: Sandra L Ettema, MD, PhD Medical College of Wisconsin
Study Chair: Laura Brusky, MD Medical College of Wisconsin
Principal Investigator: B Tucker Woodson, MD Medical College of Wisconsin
Medical College of Wisconsin
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP