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

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 Overview

• Status: Completed
• Conditions: Sleep Apnea; Sleep Disordered Breathing
• Intervention / Treatment: Device: 14 days of placebo therapy; Device: 14 days of CPAP therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: ResMed
• Investigators: Study Chair: Hersel Raff, PhD, Medical College of Wisconsin; Study Chair: Sandra L Ettema, MD, PhD, Medical College of Wisconsin; Study Chair: Laura Brusky, MD, Medical College of Wisconsin; Principal Investigator: B Tucker Woodson, MD, Medical College of Wisconsin

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start: November 15, 2004
• Primary Completion (Actual): December 15, 2011
• Study Completion (Actual): December 15, 2011

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (Estimate): September 8, 2010

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Salivary Cortisol; Apnea; automatic positive airway pressure (APAP); continuous positive airway pressure (CPAP); Sleep Apnea and/or any Sleep Disordered Breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Aspiration; Apnea; Sleepiness
• Other Study ID Numbers: 481-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No