Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
NCT ID: NCT01196117
Last Updated: 2020-04-01
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
18 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-11-15
Study Completion Date
2011-12-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Sleep Apnea
Sleep Disordered Breathing
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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14 days of Placebo therapy, then CPAP
14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
Group Type
PLACEBO_COMPARATOR
14 days of placebo therapy
Intervention Type
DEVICE
14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
14 days of CPAP therapy
14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
Group Type
ACTIVE_COMPARATOR
14 days of CPAP therapy
Intervention Type
DEVICE
14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
Interventions
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14 days of placebo therapy
14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
Intervention Type
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
Intervention Type
DEVICE
Other Intervention Names
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placebo arm, non-CPAP arm
CPAP arm
Eligibility Criteria
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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
* 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
* Pregnant women
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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ResMed
INDUSTRY
Sponsor Role
collaborator
Medical College of Wisconsin
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Hersel Raff, PhD
Role: STUDY_CHAIR
Medical College of Wisconsin
Sandra L Ettema, MD, PhD
Role: STUDY_CHAIR
Medical College of Wisconsin
Laura Brusky, MD
Role: STUDY_CHAIR
Medical College of Wisconsin
B Tucker Woodson, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Froedtert West Clinics - Otolaryngology Clinc
Milwaukee, Wisconsin, United States
Site Status
Countries
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United States
References
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Reference Type
DERIVED
Other Identifiers
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481-04
Identifier Type: -
Identifier Source: org_study_id
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