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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2010 by Medical College of Wisconsin.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

ResMed

Information provided by:

Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT01196117

First received: September 3, 2010

Last updated: September 29, 2010

Last verified: September 2010

History of Changes

Purpose

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	Intervention
Sleep Apnea Sleep Disordered Breathing	Device: 14 days of CPAP therapy Device: 14 days of placebo therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone butyrate Hydrocortisone valerate Hydrocortisone probutate

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

Salivary Cortisol Level [ Time Frame: throughout the patient's 28 day participation ] [ Designated as safety issue: No ]
Salivary Cortisol Level in relation to Placebo and continuous positive airway pressure (CPAP) use

Secondary Outcome Measures:

Epworth Sleepiness Score (ESS) [ Time Frame: throughout the patient's 28 day participation ] [ Designated as safety issue: No ]
Epworth Sleepiness Score in relation to Placebo and continuous positive airway pressure (CPAP) use

Enrollment:	18
Study Start Date:	November 2004
Estimated Study Completion Date:	October 2010
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
Placebo Comparator: 14 days of Placebo therapy 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

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196117

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

Publications:

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Merrit SL, Schnyders HC, Mercer P, Zhou X: The sensitivity of pupillography to circadian aspects of sleepiness. J Sleep Research 1998; 7(Sup 2): 176

Additional 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. Epub 2011 Apr 26. No abstract available.

Responsible Party:	B. Tucker Woodson, MD Principal Investigator, Medical College of Wisconsin (MCW)
ClinicalTrials.gov Identifier:	NCT01196117 History of Changes
Other Study ID Numbers:	481-04
Study First Received:	September 3, 2010
Last Updated:	September 29, 2010
Health Authority:	United States: Institutional Review Board

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
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders

Nervous System Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013

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