Trial Outcomes & Findings for Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea (NCT NCT01196117)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Difference between Baseline(Day 0) and Average of Day 1,7,14.

Results posted on

2020-04-01

Participant Flow

Participants were recruited from sleep clinic patients scheduled for polysomnography.

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.

Participant milestones

Participant milestones
Measure	14 Days of Placebo Therapy 14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation	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
Placebo, Then CPAP STARTED	18	0
Placebo, Then CPAP COMPLETED	18	0
Placebo, Then CPAP NOT COMPLETED	0	0
CPAP STARTED	0	18
CPAP COMPLETED	0	18
CPAP NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=18 Participants Participants received 14 days of placebo therapy then 14 days of continuous positive airway pressure (CPAP) therapy
Age, Continuous	47 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Apnea-hyponea Index (AHI)	30.8 units on a scale STANDARD_DEVIATION 32.1 • n=5 Participants
Body Mass Index	33.8 kg/m^2 STANDARD_DEVIATION 6.2 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	14 Days of Placebo Therapy n=18 Participants 14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation	14 Days of CPAP Therapy n=18 Participants 14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement
Epworth Sleepiness Score (ESS)	10.7 units on a scale Interval 8.5 to 12.9	8.9 units on a scale Interval 6.8 to 11.2

SECONDARY outcome

Timeframe: 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