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

Study Overview
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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.

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.

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

Conditions
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Sleep Apnea, Sleep Disordered Breathing

Intervention / Treatment
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* Device: 14 days of placebo therapy
* Device: 14 days of CPAP therapy


Participation Criteria
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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 Exclusion Criteria: Ages 17 and under Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 14 days of Placebo therapy, then CPAP<br>14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation | Device: 14 days of placebo therapy<br>* 14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation<br>* Other names: placebo arm, non-CPAP arm;|
| Active Comparator: 14 days of CPAP therapy<br>14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation | Device: 14 days of CPAP therapy<br>* 14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation<br>* Other names: CPAP arm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Cortisol Level | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. Samples were collected at  7am and  11pm on each Day: 0, 1, 7 and 14 through a salivary swab. | Difference between Baseline(Day 0) and Average of Day 1,7,14. | 
| Epworth Sleepiness Score (ESS) | Epworth Sleepiness Score (ESS) is a scale to assess sleepiness during waking hours. The scale ranges from 0-24 with higher scores indicative of greater sleepiness. | Difference between Baseline(Day 0) and Average of Day 1,7,14. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at  7am, Day 0 | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. | Day 0, 7am | 
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at  11pm, Day 0 | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. | Day 0, 11pm | 
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at  7am, Day 1 | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. | Day 1, 7am | 
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at  11pm, Day 1 | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. | Day 1, 11pm | 
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at   7am, Day 7 | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. | Day 7, 7am | 
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at  11pm, Day 7 | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. | Day 7, 11pm | 
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at  7am, Day 14 | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. | Day 14, 7am | 
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at  11pm, Day 14 | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l. | Day 14, 11pm | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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automatic positive airway pressure (APAP), continuous positive airway pressure (CPAP), Salivary Cortisol, Apnea, Sleep Apnea and/or any Sleep Disordered Breathing