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CompletedNCT01196117Updated Apr 1, 2020Results posted

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

An interventional study of 14 days of placebo therapy and 14 days of CPAP therapy in Sleep Apnea and Sleep Disordered Breathing, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep Apnea
  • Sleep Disordered Breathing

Keywords

  • automatic positive airway pressure (APAP)
  • continuous positive airway pressure (CPAP)
  • Salivary Cortisol
  • Apnea
  • Sleep Apnea and/or any Sleep Disordered Breathing
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 18 is below the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Ages 17 and under
  • Pregnant women
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Placebo comparator
    14 days of Placebo therapy, then CPAP

    14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation

    Device: 14 days of placebo therapy

  • 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

Interventions

  • Device14 days of placebo therapy

    14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation

    Also known as: placebo arm, non-CPAP arm

  • Device14 days of CPAP therapy

    14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation

    Also known as: CPAP arm

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Results

Posted Apr 1, 2020
Limitations and caveats
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.

Participant flow

Participants were recruited from sleep clinic patients scheduled for polysomnography.

Placebo, Then CPAP
Participant flow — Placebo, Then CPAP
Milestone14 Days of Placebo Therapy14 Days of Continuous Positive Airway Pressure (CPAP) Therapy
Started180
Completed180
Not completed00
CPAP
Participant flow — CPAP
Milestone14 Days of Placebo Therapy14 Days of Continuous Positive Airway Pressure (CPAP) Therapy
Started018
Completed018
Not completed00

Outcome measures

PrimarySalivary 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.

No measurements were reported for this outcome.

PrimaryEpworth 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.
Reported as:
Median · units on a scale
Epworth Sleepiness Score (ESS)
units on a scale14 Days of Placebo Therapy, Then CPAP14 Days of CPAP Therapy
Epworth Sleepiness Score (ESS)10.7 (8.5 to 12.9)8.9 (6.8 to 11.2)
Statistical analysis
  • 14 Days of Placebo Therapy, Then CPAP vs 14 Days of CPAP Therapy · Wilcoxon (Mann-Whitney) · p = 0.0009
SecondarySalivary 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
Reported as:
Median · nmol/l
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0
nmol/lCPAP>= 3 Hours Per NightCPAP<3 Hours Per Night
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 012.5 (7.6 to 20.8)12.1 (7.2 to 20.5)
Statistical analysis
  • CPAP>= 3 Hours Per Night vs CPAP<3 Hours Per Night · Wilcoxon (Mann-Whitney) · p = 0.8938
SecondarySalivary 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
Reported as:
Median · nmol/l
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0
nmol/lCPAP>= 3 Hours Per NightCPAP<3 Hours Per Night
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 03.2 (1.6 to 6.4)1.2 (0.6 to 2.6)
Statistical analysis
  • CPAP>= 3 Hours Per Night vs CPAP<3 Hours Per Night · Wilcoxon (Mann-Whitney) · p = <0.014
SecondarySalivary 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
Reported as:
Median · nmol/l
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1
nmol/lCPAP>= 3 Hours Per NightCPAP<3 Hours Per Night
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 17.4 (4.4 to 12.2)13.6 (8.1 to 23.0)
Statistical analysis
  • CPAP>= 3 Hours Per Night vs CPAP<3 Hours Per Night · Wilcoxon (Mann-Whitney) · p = <0.0200
SecondarySalivary 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
Reported as:
Median · nmol/l
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1
nmol/lCPAP>= 3 Hours Per NightCPAP<3 Hours Per Night
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 12.2 (1.1 to 4.4)1.8 (0.9 to 3.7)
Statistical analysis
  • CPAP>= 3 Hours Per Night vs CPAP<3 Hours Per Night · Wilcoxon (Mann-Whitney) · p = 0.1321
SecondarySalivary 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
Reported as:
Mean · nmol/l
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7
nmol/lCPAP>= 3 Hours Per NightCPAP<3 Hours Per Night
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 79.9 (6.0 to 16.4)13.3 (7.9 to 22.3)
Statistical analysis
  • CPAP>= 3 Hours Per Night vs CPAP<3 Hours Per Night · Wilcoxon (Mann-Whitney) · p = <0.2490
SecondarySalivary 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
Reported as:
Median · nmol/l
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7
nmol/lCPAP>= 3 Hours Per NightCPAP<3 Hours Per Night
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 73.0 (1.5 to 6.1)2.5 (1.2 to 5.1)
Statistical analysis
  • CPAP>= 3 Hours Per Night vs CPAP<3 Hours Per Night · Wilcoxon (Mann-Whitney) · p = 0.5139
SecondarySalivary 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
Reported as:
Median · nmol/l
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14
nmol/lCPAP>= 3 Hours Per NightCPAP<3 Hours Per Night
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 149.2 (5.6 to 15.3)15.0 (8.9 to 25.3)
Statistical analysis
  • CPAP>= 3 Hours Per Night vs CPAP<3 Hours Per Night · Wilcoxon (Mann-Whitney) · p = 0.0597
SecondarySalivary 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
Reported as:
Median · nmol/l
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14
nmol/lCPAP>= 3 Hours Per NightCPAP<3 Hours Per Night
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 141.9 (1.0 to 4.0)2.2 (1.0 to 4.5)
Statistical analysis
  • CPAP>= 3 Hours Per Night vs CPAP<3 Hours Per Night · Wilcoxon (Mann-Whitney) · p = 0.2134

Adverse events

Collected over Adverse Events were observed in a non-systematic way over the course of approximately 6 years the patients were enrolled.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
14 Days of Placebo Therapy, Then CPAP0/18 (0%)0/18 (0%)0/18 (0%)
14 Days of CPAP Therapy0/18 (0%)0/18 (0%)0/18 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Study Participants
Mean47 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)All Study Participants
Female9
Male9
Apnea-hyponea Index (AHI)
Apnea-hyponea Index (AHI)(units on a scale)All Study Participants
Mean30.8 ± 32.1
Body Mass Index
Body Mass Index(kg/m^2)All Study Participants
Mean33.8 ± 6.2
08

Study locations

1 site
  • Froedtert West Clinics - Otolaryngology Clinc
    Milwaukee, Wisconsin 53226, United States
09

References and documents

Publications

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Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01196117
Lead sponsor
Medical College of Wisconsin
Collaborators
ResMed
Responsible party
Sponsor
First posted
Sep 8, 2010
Start date
Nov 15, 2004
Primary completion
Dec 15, 2011
Completion
Dec 15, 2011
Results posted
Apr 1, 2020
Last update
Apr 1, 2020

Study contacts

Hersel Raff, PhD
study chair · Medical College of Wisconsin
Sandra L Ettema, MD, PhD
study chair · Medical College of Wisconsin
Laura Brusky, MD
study chair · Medical College of Wisconsin
B Tucker Woodson, MD
principal investigator · Medical College of Wisconsin

Oversight

Data monitoring committee
No
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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