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

• ClinicalTrials.gov Identifier: NCT01196117
• Recruitment Status: Completed
• First Posted: September 8, 2010
• Results First Posted: April 1, 2020
• Last Update Posted: April 1, 2020
• Sponsor: Medical College of Wisconsin
• Collaborator: ResMed
• Information provided by (Responsible Party): Medical College of Wisconsin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea; Sleep Disordered Breathing	Device: 14 days of placebo therapy; Device: 14 days of CPAP therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
• Study Start Date: November 15, 2004
• Actual Primary Completion Date: December 15, 2011
• Actual Study Completion Date: December 15, 2011

Arms and Interventions

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 Name: 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 Name: CPAP arm

Outcome Measures

Primary Outcome Measures :

1. Salivary Cortisol Level [ Time Frame: Difference between Baseline(Day 0) and Average of Day 1,7,14. ]
   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.
2. Epworth Sleepiness Score (ESS) [ Time Frame: Difference between Baseline(Day 0) and Average of Day 1,7,14. ]
   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.

Secondary Outcome Measures :

1. Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0 [ Time Frame: Day 0, 7am ]
   Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.
2. Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0 [ Time Frame: Day 0, 11pm ]
   Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.
3. Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1 [ Time Frame: Day 1, 7am ]
   Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.
4. Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1 [ Time Frame: Day 1, 11pm ]
   Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.
5. Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7 [ Time Frame: Day 7, 7am ]
   Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.
6. Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7 [ Time Frame: Day 7, 11pm ]
   Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.
7. Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14 [ Time Frame: Day 14, 7am ]
   Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.
8. Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14 [ Time Frame: Day 14, 11pm ]
   Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is <4.2 nmol/l.

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Wisconsin

Froedtert West Clinics - Otolaryngology Clinc

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

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

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Raff H, Ettema SL, Eastwood DC, Woodson BT. Salivary cortisol in obstructive sleep apnea: the effect of CPAP. Endocrine. 2011 Aug;40(1):137-9. doi: 10.1007/s12020-011-9474-1. Epub 2011 Apr 26.

• Responsible Party: Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT01196117
• Other Study ID Numbers: 481-04
• First Posted: September 8, 2010
• Results First Posted: April 1, 2020
• Last Update Posted: April 1, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Medical College of Wisconsin:

automatic positive airway pressure (APAP); continuous positive airway pressure (CPAP); Salivary Cortisol; Apnea; Sleep Apnea and/or any Sleep Disordered Breathing

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Respiratory Aspiration; Sleepiness; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes