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

Information source: Medical College of Wisconsin
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sleep Apnea; Sleep Disordered Breathing

Intervention: 14 days of CPAP therapy (Device); 14 days of placebo therapy (Device)

Phase: N/A

Status: Completed

Sponsored by: Medical College of Wisconsin

Official(s) and/or principal investigator(s):
Hersel Raff, PhD, Study Chair, Affiliation: Medical College of Wisconsin
Sandra L Ettema, MD, PhD, Study Chair, Affiliation: Medical College of Wisconsin
Laura Brusky, MD, Study Chair, Affiliation: Medical College of Wisconsin
B Tucker Woodson, MD, Principal Investigator, Affiliation: Medical College of Wisconsin


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Salivary Cortisol Level

Secondary outcome: Epworth Sleepiness Score (ESS)

Detailed description: 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.


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


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

Locations and Contacts

Froedtert West Clinics - Otolaryngology Clinc, Milwaukee, Wisconsin 53226, United States
Additional Information

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Starting date: November 2004
Last updated: April 8, 2014

Page last updated: August 23, 2015

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