Sleep ApneaNCT01196117

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

A study testing 14 days of CPAP therapy in people with Sleep Apnea and Sleep Disordered Breathing, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Sleep Apnea, Sleep Disordered Breathing
What is being tested?: 14 days of CPAP therapy
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2004to 15 Dec 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Ages 17 and under
Pregnant women

Trial locations and contacts

1 site in 1 country.

United States1 site

Froedtert West Clinics - Otolaryngology Clinc
Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

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.

Conditions: Sleep Apnea, Sleep Disordered Breathing
Being tested: 14 days of placebo therapy, 14 days of CPAP therapy
Keywords: automatic positive airway pressure (APAP), continuous positive airway pressure (CPAP), Salivary Cortisol, Apnea, Sleep Apnea and/or any Sleep Disordered Breathing
Medical subject headings: Sleep Apnea Syndromes, Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

14 days of placebo therapyDevice
Also called placebo arm, non-CPAP arm
14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
14 days of CPAP therapyDevice
Also called CPAP arm
14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation

Study groups in NCT01196117
Study group	Role	What they receive
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 Receives: Device: 14 days of placebo therapy
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 Receives: Device: 14 days of CPAP therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (8)

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.
Measured: Day 0, 7am
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14, 11pm

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 200415 Dec 2011

First posted8 Sep 2010 (estimated)
Study start15 Nov 2004
Primary completion15 Dec 2011
Study completion15 Dec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (48)Papers the sponsor has linked to this study.
Other trials for Sleep ApneaStudies of the same condition, open and under way.
More trials run by Medical College of WisconsinThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01196117
Sponsor's protocol ID: 481-04
Status last verified: Mar 2020
First submitted: 3 Sep 2010
Last updated: 1 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 216912
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.
PubMed 3934481
Sullivan CE, Issa FG. Obstructive sleep apnea. Clin Chest Med. 1985 Dec;6(4):633-50.
PubMed 3936665
Pasquali R, Colella P, Cirignotta F, Mondini S, Gerardi R, Buratti P, Rinaldi Ceroni A, Tartari F, Schiavina M, Melchionda N, et al. Treatment of obese patients with obstructive sleep apnea syndrome (OSAS): effect of weight loss and interference of otorhinolaryngoiatric pathology. Int J Obes. 1990 Mar;14(3):207-17.
PubMed 2341227
Onusko E. Diagnosing secondary hypertension. Am Fam Physician. 2003 Jan 1;67(1):67-74.
PubMed 12537168
Weitzman ED, Czeisler CA, Zimmerman JC, Moore-Ede MC. Biological rhythms in man: relationship of sleep-wake, cortisol, growth hormone, and temperature during temporal isolation. Adv Biochem Psychopharmacol. 1981;28:475-99. No abstract available.
PubMed 7010946
Wittels EH. Obesity and hormonal factors in sleep and sleep apnea. Med Clin North Am. 1985 Nov;69(6):1265-80. doi: 10.1016/s0025-7125(16)30986-5.
PubMed 3906303
Entzian P, Linnemann K, Schlaak M, Zabel P. Obstructive sleep apnea syndrome and circadian rhythms of hormones and cytokines. Am J Respir Crit Care Med. 1996 Mar;153(3):1080-6. doi: 10.1164/ajrccm.153.3.8630548.
PubMed 8630548
Bratel T, Wennlund A, Carlstrom K. Pituitary reactivity, androgens and catecholamines in obstructive sleep apnoea. Effects of continuous positive airway pressure treatment (CPAP). Respir Med. 1999 Jan;93(1):1-7. doi: 10.1016/s0954-6111(99)90068-9.
PubMed 10464840
Vgontzas AN, Chrousos GP. Sleep, the hypothalamic-pituitary-adrenal axis, and cytokines: multiple interactions and disturbances in sleep disorders. Endocrinol Metab Clin North Am. 2002 Mar;31(1):15-36. doi: 10.1016/s0889-8529(01)00005-6.
PubMed 12055986
Lanfranco F, Gianotti L, Maccario M. Endocrine and metabolic alterations in obstructive sleep apnea syndrome. J Endocrinol Invest. 2003 Jun;26(6):491-2. doi: 10.1007/BF03345208. No abstract available.
PubMed 12952359
Grunstein RR, Handelsman DJ, Lawrence SJ, Blackwell C, Caterson ID, Sullivan CE. Neuroendocrine dysfunction in sleep apnea: reversal by continuous positive airways pressure therapy. J Clin Endocrinol Metab. 1989 Feb;68(2):352-8. doi: 10.1210/jcem-68-2-352.
PubMed 2493027
Cooper BG, White JE, Ashworth LA, Alberti KG, Gibson GJ. Hormonal and metabolic profiles in subjects with obstructive sleep apnea syndrome and the acute effects of nasal continuous positive airway pressure (CPAP) treatment. Sleep. 1995 Apr;18(3):172-9.
PubMed 7610313
Grunstein RR, Stewart DA, Lloyd H, Akinci M, Cheng N, Sullivan CE. Acute withdrawal of nasal CPAP in obstructive sleep apnea does not cause a rise in stress hormones. Sleep. 1996 Dec;19(10):774-82. doi: 10.1093/sleep/19.10.774.
PubMed 9085485
Meston N, Davies RJ, Mullins R, Jenkinson C, Wass JA, Stradling JR. Endocrine effects of nasal continuous positive airway pressure in male patients with obstructive sleep apnoea. J Intern Med. 2003 Nov;254(5):447-54. doi: 10.1046/j.1365-2796.2003.01212.x.
PubMed 14535966

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea
ClinicalTrials.gov ID: NCT01196117
Acronym / sponsor ID: 481-04
Conditions: 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
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Medical College of WisconsinUniversity, hospital or other
Collaborators: ResMed
Study start: 15 Nov 2004
Primary completion: 15 Dec 2011 (actual)
Study completion: 15 Dec 2011 (actual)
First posted: 8 Sep 2010 (estimated)
Results: Posted 1 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
14 days of Placebo therapy, then CPAP	Placebo comparator	Device: 14 days of placebo therapy14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
14 days of CPAP therapy	Active comparator	Device: 14 days of CPAP therapy14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

Ages 17 and under
Pregnant women

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
14 days of placebo therapyAlso: placebo arm, non-CPAP arm14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation	Device	14 days of Placebo therapy, then CPAP
14 days of CPAP therapyAlso: CPAP arm14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation	Device	14 days of CPAP therapy

Primary outcome

Salivary Cortisol Level
Time frame: 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)
Time frame: 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.

8 secondary outcomes

Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 0
Time frame: Day 0, 7am
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 0
Time frame: Day 0, 11pm
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 1
Time frame: Day 1, 7am
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 1
Time frame: Day 1, 11pm
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~ 7am, Day 7
Time frame: Day 7, 7am
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 7
Time frame: Day 7, 11pm
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~7am, Day 14
Time frame: Day 14, 7am
Salivary Cortisol in Participants Who Used Continuous Positive Airway Pressure (CPAP) at ~11pm, Day 14
Time frame: Day 14, 11pm

Results and safety

Results posted to the registry on 1 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
14 Days of Placebo Therapy	18	18
14 Days of Continuous Positive Airway Pressure (CPAP) Therapy	0	0

Primary outcome: Salivary Cortisol Level

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

Population analysed: 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.

Primary outcome: Epworth Sleepiness Score (ESS)

Time frame: Difference between Baseline(Day 0) and Average of Day 1,7,14.. Median (95% Confidence Interval). Unit: units on a scale

Measure	14 Days of Placebo Therapy, Then CPAP n = 18	14 Days of CPAP Therapy n = 18
Value	10.7 (8.5 to 12.9)	8.9 (6.8 to 11.2)

14 Days of Placebo Therapy, Then CPAP vs 14 Days of CPAP Therapy: p = 0.0009, Wilcoxon (Mann-Whitney)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were observed in a non-systematic way over the course of approximately 6 years the patients were enrolled.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
14 Days of Placebo Therapy, Then CPAP	0 of 18 (0%)	0 of 18 (0%)	0 of 18
14 Days of CPAP Therapy	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 216912Block 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.
Background: PubMed 3934481Bradley 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.
Background: PubMed 3936665Sullivan CE, Issa FG. Obstructive sleep apnea. Clin Chest Med. 1985 Dec;6(4):633-50.
Background: PubMed 2341227Pasquali R, Colella P, Cirignotta F, Mondini S, Gerardi R, Buratti P, Rinaldi Ceroni A, Tartari F, Schiavina M, Melchionda N, et al. Treatment of obese patients with obstructive sleep apnea syndrome (OSAS): effect of weight loss and interference of otorhinolaryngoiatric pathology. Int J Obes. 1990 Mar;14(3):207-17.
Background: PubMed 12537168Onusko E. Diagnosing secondary hypertension. Am Fam Physician. 2003 Jan 1;67(1):67-74.
Background: PubMed 7010946Weitzman ED, Czeisler CA, Zimmerman JC, Moore-Ede MC. Biological rhythms in man: relationship of sleep-wake, cortisol, growth hormone, and temperature during temporal isolation. Adv Biochem Psychopharmacol. 1981;28:475-99. No abstract available.
Background: PubMed 3906303Wittels EH. Obesity and hormonal factors in sleep and sleep apnea. Med Clin North Am. 1985 Nov;69(6):1265-80. doi: 10.1016/s0025-7125(16)30986-5.
Background: PubMed 8630548Entzian P, Linnemann K, Schlaak M, Zabel P. Obstructive sleep apnea syndrome and circadian rhythms of hormones and cytokines. Am J Respir Crit Care Med. 1996 Mar;153(3):1080-6. doi: 10.1164/ajrccm.153.3.8630548.
Background: PubMed 10464840Bratel T, Wennlund A, Carlstrom K. Pituitary reactivity, androgens and catecholamines in obstructive sleep apnoea. Effects of continuous positive airway pressure treatment (CPAP). Respir Med. 1999 Jan;93(1):1-7. doi: 10.1016/s0954-6111(99)90068-9.
Background: PubMed 12055986Vgontzas AN, Chrousos GP. Sleep, the hypothalamic-pituitary-adrenal axis, and cytokines: multiple interactions and disturbances in sleep disorders. Endocrinol Metab Clin North Am. 2002 Mar;31(1):15-36. doi: 10.1016/s0889-8529(01)00005-6.
Background: PubMed 12952359Lanfranco F, Gianotti L, Maccario M. Endocrine and metabolic alterations in obstructive sleep apnea syndrome. J Endocrinol Invest. 2003 Jun;26(6):491-2. doi: 10.1007/BF03345208. No abstract available.
Background: PubMed 2493027Grunstein RR, Handelsman DJ, Lawrence SJ, Blackwell C, Caterson ID, Sullivan CE. Neuroendocrine dysfunction in sleep apnea: reversal by continuous positive airways pressure therapy. J Clin Endocrinol Metab. 1989 Feb;68(2):352-8. doi: 10.1210/jcem-68-2-352.
Individual participant dataSharing planned: No

Related trials for Sleep Apnea

RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 14 days of CPAP therapy in people with Sleep Apnea and Sleep Disordered Breathing, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary Cortisol Level (time frame: Difference between Baseline(Day 0) and Average of Day 1,7,14.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01196117, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2020.