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

This study has been completed.
Sponsor:
Collaborator:
ResMed
Information provided by (Responsible Party):
B Tucker Woodson, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01196117
First received: September 3, 2010
Last updated: April 8, 2014
Last verified: April 2014
  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:


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
Study Completion Date: December 2011
Primary Completion Date: December 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Sullivan CD and Issa FG: Obstructive sleep apnea. Clin Chest Med 1985; 6(4): 633-650.
Onusko E: Diagnosing secondary hypertension. Am Fam Phys 2003; 67(1): 67-74.
Rapoport D, Rothenberg SA, Hollander CS, Goldring RM: Obstructive sleep apnea (OSA) and the neuroendocrine "stress" axis. Am Rev Respir Dis 1991; 143: A382 (abstract)
Raff H: Salivary cortisol: a useful measurement in the diagnosis of cushing's syndrome and the evaluation of the hypothalamic-pituitary-adrenal axis. The Endocrinologist 2000; 10: 9-17
Nater UM, Rohleder N, Gaab J, Berger S, Jud A, Wolf JM, Ehlert U: Reactivity of human salivary alpha-amylase in a psychosocial stress paradigm. J Psychophysiol 2002; 16(4): 245 (abstract)
Nater UM, La Marca R, Florin L, Koller MM, Ehlert U: The relationship between salivary alpha-amylase and plasma catecholamines. J Psychophysiol 2003; 17(3): 170 (abstract).
Graeber RC: Aircrew fatigue and circadian rhythmicity. In: Wiener E, Nagel DC, eds. Human Factors in Aviation. New York: Academic Press; 1987: 1-48
Hoddes E, Zarcone V, Smythe H, Phillips R, Dement WC: Quantification of sleepiness: anew approach. Psychophysiol 1973; 10: 431-436
Lowenstein O, Feinberg R, Loewenfeld ID: Pupillary movements during acute and chronic fatigue. Investigative Ophthalmolog 1963; 2: 138-157
Merrit SL, Schnyders HC, Mercer P: Circadian aspects of papillary unrest reflecting daytime sleepiness. Sleep Research Online 1999; 2(Sup 1): 773
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):
Responsible Party: B Tucker Woodson, Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01196117     History of Changes
Other Study ID Numbers: 481-04
Study First Received: September 3, 2010
Last Updated: April 8, 2014
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
Sleep Apnea Syndromes
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014