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NCT01196117 · ClinicalTrials.gov registry record · NA

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

A NA study of Sleep Apnea and Sleep Disordered Breathing, sponsored by Medical College of Wisconsin.

Completed
Registry status
NA
Development phase
18
Enrollment target
1
Study location

NCT01196117: Completed NA study of Sleep Apnea and Sleep Disordered Breathing, sponsored by Medical College of Wisconsin.

NCT01196117 is a NA study of Sleep Apnea and Sleep Disordered Breathing that has completed, run by Medical College of Wisconsin. The registered enrollment target is 18 participants, below the 2,989-participant average among 36 other Sleep Apnea trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01196117, a NA study of Sleep Apnea and Sleep Disordered Breathing, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
NA
Development phase
18 participants
Enrollment target
1
Study location

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.

Primary Outcome

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.

Conditions Studied

Sleep Apnea Sleep Disordered Breathing

Interventions

  • DEVICE 14 days of placebo therapy
  • DEVICE 14 days of CPAP therapy

Study Locations (1)

Wisconsin

  • Froedtert West Clinics - Otolaryngology Clinc - Milwaukee

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2004-11-15
Est. Completion 2011-12-15
Phase NA
Medical College of Wisconsin

447 total trials

What the finished NCT01196117 record still lists

NCT01196117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 2,989-participant average among 36 other Sleep Apnea trials with a reported enrollment target (99% lower).

The record links to 2 conditions, with Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which 14 days of placebo therapy is the first listed.

NCT01196117 reports a single indexed study location in Wisconsin.

Frequently Asked Questions

What is clinical trial NCT01196117 about?

NCT01196117 is a clinical study titled "Sleepiness and the Effects of CPAP on Salivary Cortisol and Alpha-Amylase Levels in Patients With Sleep Apnea". 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 press...

What is the current status of trial NCT01196117?

This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2004-11-15. Estimated completion is 2011-12-15.

What conditions does trial NCT01196117 study?

This clinical trial studies the following conditions: Sleep Apnea, Sleep Disordered Breathing.

What interventions are being tested in trial NCT01196117?

The interventions under investigation include: 14 days of placebo therapy (DEVICE), 14 days of CPAP therapy (DEVICE).

Who is sponsoring clinical trial NCT01196117?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01196117 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Sleep Apnea

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01196117's enrollment target sits among peer trials

18 33rd of 36 higher than 4 of 36 other Sleep Apnea trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01196117, the US trial registry maintained by the National Library of Medicine. NCT01196117 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.