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| Name | Class |
|---|---|
| ResMed | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14 days of Placebo therapy, then CPAP | Placebo Comparator | 14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation |
|
| 14 days of CPAP therapy | Active Comparator | 14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14 days of placebo therapy | Device | 14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| B Tucker Woodson, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert West Clinics - Otolaryngology Clinc | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 216912 | Background | Block AJ, Boysen PG, Wynne JW, Hunt LA. Sleep apnea, hypopnea and oxygen desaturation in normal subjects. A strong male predominance. N Engl J Med. 1979 Mar 8;300(10):513-7. doi: 10.1056/NEJM197903083001001. | |
| 3934481 | Background | Bradley TD, Phillipson EA. Pathogenesis and pathophysiology of the obstructive sleep apnea syndrome. Med Clin North Am. 1985 Nov;69(6):1169-85. doi: 10.1016/s0025-7125(16)30981-6. |
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Participants without prior treatment of obstructive sleep apnea (OSA) or overt airway structural pathology that would interfere with continuous positive airway pressure (CPAP) were recruited.
Participants were recruited from sleep clinic patients scheduled for polysomnography.
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| ID | Title | Description |
|---|---|---|
| FG000 | 14 Days of Placebo Therapy | 14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation |
| FG001 | 14 Days of Continuous Positive Airway Pressure (CPAP) Therapy | 14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo, Then CPAP |
| |||||||||||||
| CPAP |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants received 14 days of placebo therapy then 14 days of continuous positive airway pressure (CPAP) therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We have made a best faith effort from a manuscript to determine the primary outcome measure; Salivary Cortisol Level; but access to the primary data has been lost and it additionally cannot be found in the manuscript. Despite all efforts to contact the PI/study team members, the statisticians and date are gone. | Posted | Difference between Baseline(Day 0) and Average of Day 1,7,14. |
|
Adverse Events were observed in a non-systematic way over the course of approximately 6 years the patients were enrolled.
Given the minimal risk nature of this study, adverse events were collected via a non-systematic assessment. The primary risks were loss of confidentiality, some possible discomfort from the mask and the possibility of an adverse event related to the mucolytic, guaifenesin. None of these possible adverse events occurred and they were not collected in a systematic way.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 14 Days of Placebo Therapy, Then CPAP | 14 days of placebo therapy: 14 days of placebo therapy then 14 days of continuous positive airway pressure (CPAP) therapy |
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The limitation of this trial is the results were entered strictly from a manuscript published in 2011. Despite repeated attempts to reach out, the original study team members, statisticians and data are no longer available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| B. Tucker Woodson | Medical College of Wisconsin | 414-805-7667 | bwoodson@mcw.edu |
Not provided
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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|
| 14 days of CPAP therapy | Device | 14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation |
|
|
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 |
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| Background | 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 |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Apnea-hyponea Index (AHI) | AHI<5 Normal <=5 AHI <15 Mild Sleep Apnea 15<= AHI <30 Moderate Sleep Apnea AHI>=30 Severe Sleep Apnea | Mean | Standard Deviation | units on a scale |
|
| Body Mass Index | <18.5 Underweight range >=18.5 BMI <24.9 Healthy weight range >25.0 BMI < 29.9 Overweight range >30.0 BMI <29.9 Obese weight range | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| 14 Days of CPAP Therapy |
14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement |
|
| Primary | 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. | Posted | Median | 95% Confidence Interval | units on a scale | Difference between Baseline(Day 0) and Average of Day 1,7,14. |
|
|
|
|
| Secondary | 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. | A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night | Posted | Median | 95% Confidence Interval | nmol/l | Day 0, 7am |
|
|
|
|
| Secondary | 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. | A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night | Posted | Median | 95% Confidence Interval | nmol/l | Day 0, 11pm |
|
|
|
|
| Secondary | 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. | A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night | Posted | Median | 95% Confidence Interval | nmol/l | Day 1, 7am |
|
|
|
|
| Secondary | 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. | A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night | Posted | Median | 95% Confidence Interval | nmol/l | Day 1, 11pm |
|
|
|
|
| Secondary | 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. | A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night | Posted | Mean | 95% Confidence Interval | nmol/l | Day 7, 7am |
|
|
|
|
| Secondary | 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. | Posted | Median | 95% Confidence Interval | nmol/l | Day 7, 11pm |
|
|
|
|
| Secondary | 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. | A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night | Posted | Median | 95% Confidence Interval | nmol/l | Day 14, 7am |
|
|
|
|
| Secondary | 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. | A sub-analysis was performed on those using CPAP>= 3 hours per night compared to those who used CPAP< 3 hours per night | Posted | Median | 95% Confidence Interval | nmol/l | Day 14, 11pm |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 14 Days of CPAP Therapy | 14 days of continuous positive airway pressure (CPAP) therapy | 0 | 18 | 0 | 18 | 0 | 18 |
Not provided
Not provided
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |