Clinical trial NCT01196117: Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
Official title: Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Sleep Disordered Breathing
Keywords: automatic positive airway pressure (APAP)
continuous positive airway pressure (CPAP)
Salivary Cortisol
Apnea
Sleep Apnea and/or any Sleep Disordered Breathing
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: ResMed
First posted: 2010-09-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Salivary Cortisol Level
timeFrame: Difference between Baseline(Day 0) and Average of Day 1,7,14.
measure: Epworth Sleepiness Score (ESS)
timeFrame: Difference between Baseline(Day 0) and Average of Day 1,7,14.
Secondary outcomes:
measure: Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0
timeFrame: Day 0, 7am
measure: Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0
timeFrame: Day 0, 11pm
measure: Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1
timeFrame: Day 1, 7am
measure: Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1
timeFrame: Day 1, 11pm
measure: Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7
timeFrame: Day 7, 7am
measure: Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7
timeFrame: Day 7, 11pm
measure: Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14
timeFrame: Day 14, 7am
measure: Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14
timeFrame: Day 14, 11pm
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert West Clinics - Otolaryngology Clinc
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Hersel Raff, PhD
role: STUDY_CHAIR
affiliation: Medical College of Wisconsin
name: Sandra L Ettema, MD, PhD
role: STUDY_CHAIR
affiliation: Medical College of Wisconsin
name: Laura Brusky, MD
role: STUDY_CHAIR
affiliation: Medical College of Wisconsin
name: B Tucker Woodson, MD
role: PRINCIPAL_INVESTIGATOR
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