CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
14 days of placebo therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01196117
NCT01196117N/ACompleted
CompareCT.gov

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

Medical College of Wisconsin·interventional·Posted Sep 8, 2010·Updated Apr 1, 2020

In Brief

A clinical study evaluating 14 days of placebo therapy and 14 days of CPAP therapy for Sleep Apnea and Sleep Disordered Breathing. Completed, enrolled 18 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea, Sleep Disordered Breathing
CountriesUnited States
CollaboratorsResMed

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2010
Enrollment StartNov 15, 2004
Primary CompletionDec 15, 2011
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 15.8 years ago

Interventions

14 days of placebo therapydevice

14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation

14 days of CPAP therapydevice

14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation