Sleep Apnea, Sleep Disordered Breathing
Conditions
Keywords
automatic positive airway pressure (APAP), continuous positive airway pressure (CPAP), Salivary Cortisol, Apnea, Sleep Apnea and/or any Sleep Disordered Breathing
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.
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.
Interventions
DEVICE14 days of placebo therapy
14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
DEVICE14 days of CPAP therapy
14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
Sponsors
ResMed
Medical College of Wisconsin
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol Level | 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. |
| Epworth Sleepiness Score (ESS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1 | Day 1, 7am | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is \<4.2 nmol/l. |
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1 | Day 1, 11pm | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is \<4.2 nmol/l. |
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7 | Day 7, 7am | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is \<4.2 nmol/l. |
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0 | Day 0, 7am | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is \<4.2 nmol/l. |
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14 | Day 14, 7am | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is \<4.2 nmol/l. |
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14 | Day 14, 11pm | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is \<4.2 nmol/l. |
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7 | Day 7, 11pm | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is \<4.2 nmol/l. |
| Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0 | Day 0, 11pm | Salivary Cortisol was measured by enzyme-linked immunosorbent assay. The reference range for healthy adults is \<4.2 nmol/l. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from sleep clinic patients scheduled for polysomnography.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| All Study Participants Participants received 14 days of placebo therapy then 14 days of continuous positive airway pressure (CPAP) therapy | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 9 |
| Apnea-hyponea Index (AHI) | 30.8 units on a scale STANDARD_DEVIATION 32.1 |
| Body Mass Index | 33.8 kg/m^2 STANDARD_DEVIATION 6.2 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
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.
Time frame: Difference between Baseline(Day 0) and Average of Day 1,7,14.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Epworth Sleepiness Score (ESS) | 10.7 units on a scale |
| 14 Days of CPAP Therapy | Epworth Sleepiness Score (ESS) | 8.9 units on a scale |
p-value: 0.0009Wilcoxon (Mann-Whitney)
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.
Time frame: Difference between Baseline(Day 0) and Average of Day 1,7,14.
Population: 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.
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.
Time frame: Day 0, 11pm
Population: A sub-analysis was performed on those using CPAP\>= 3 hours per night compared to those who used CPAP\< 3 hours per night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0 | 3.2 nmol/l |
| 14 Days of CPAP Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0 | 1.2 nmol/l |
p-value: <0.014Wilcoxon (Mann-Whitney)
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.
Time frame: Day 1, 11pm
Population: A sub-analysis was performed on those using CPAP\>= 3 hours per night compared to those who used CPAP\< 3 hours per night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1 | 2.2 nmol/l |
| 14 Days of CPAP Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1 | 1.8 nmol/l |
p-value: 0.1321Wilcoxon (Mann-Whitney)
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.
Time frame: Day 14, 11pm
Population: A sub-analysis was performed on those using CPAP\>= 3 hours per night compared to those who used CPAP\< 3 hours per night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14 | 1.9 nmol/l |
| 14 Days of CPAP Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14 | 2.2 nmol/l |
p-value: 0.2134Wilcoxon (Mann-Whitney)
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.
Time frame: Day 7, 11pm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7 | 3.0 nmol/l |
| 14 Days of CPAP Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7 | 2.5 nmol/l |
p-value: 0.5139Wilcoxon (Mann-Whitney)
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.
Time frame: Day 0, 7am
Population: A sub-analysis was performed on those using CPAP\>= 3 hours per night compared to those who used CPAP\< 3 hours per night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0 | 12.5 nmol/l |
| 14 Days of CPAP Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0 | 12.1 nmol/l |
p-value: 0.8938Wilcoxon (Mann-Whitney)
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.
Time frame: Day 1, 7am
Population: A sub-analysis was performed on those using CPAP\>= 3 hours per night compared to those who used CPAP\< 3 hours per night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1 | 7.4 nmol/l |
| 14 Days of CPAP Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1 | 13.6 nmol/l |
p-value: <0.02Wilcoxon (Mann-Whitney)
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.
Time frame: Day 14, 7am
Population: A sub-analysis was performed on those using CPAP\>= 3 hours per night compared to those who used CPAP\< 3 hours per night
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14 | 9.2 nmol/l |
| 14 Days of CPAP Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14 | 15.0 nmol/l |
p-value: 0.0597Wilcoxon (Mann-Whitney)
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.
Time frame: Day 7, 7am
Population: A sub-analysis was performed on those using CPAP\>= 3 hours per night compared to those who used CPAP\< 3 hours per night
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 14 Days of Placebo Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7 | 9.9 nmol/l |
| 14 Days of CPAP Therapy | Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7 | 13.3 nmol/l |
p-value: <0.249Wilcoxon (Mann-Whitney)