N/A
N=18
Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
Sleep Apnea · Sleep Disordered Breathing
Bottom Line
View on ClinicalTrials.gov: NCT01196117 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Salivary Cortisol Level
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 14 days of placebo therapy (Device); 14 days of CPAP therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Salivary Cortisol Level |
— | — |
| PRIMARY Epworth Sleepiness Score (ESS) |
10.7; 8.9 | 0.0009 sig |
| SECONDARY Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0 |
12.5; 12.1 | 0.8938 |
| SECONDARY Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0 |
3.2; 1.2 | <0.014 sig |
| SECONDARY Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1 |
7.4; 13.6 | <0.0200 sig |
| SECONDARY Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1 |
2.2; 1.8 | 0.1321 |
| SECONDARY Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7 |
9.9; 13.3 | <0.2490 |
| SECONDARY Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7 |
3.0; 2.5 | 0.5139 |
| SECONDARY Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14 |
9.2; 15.0 | 0.0597 |
| SECONDARY Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14 |
1.9; 2.2 | 0.2134 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01196117). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.