Status:
COMPLETED
The Impact of Arousal Threshold in Obstructive Sleep Apnea
Lead Sponsor:
University of California, San Diego
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated ...
Detailed Description
This study is a pilot study. The investigators will test whether donepezil has important effects on the arousal threshold and on the apnea hypopnea index. Donepezil is a cholinesterase inhibitor appr...
Eligibility Criteria
Inclusion
- Ages 18-70 years
- sleep study (with apnea hypopnea index\>5)
- Diagnosis of obstructive sleep apnea
Exclusion
- Any known unstable cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease.
- Susceptible to stomach ulcers.
- Pregnant women or Nursing mothers
- Using positive airway pressure (PAP) therapy over one week or longer
- Body weight \<55kg
- History of hypersensitivity to Afrin, Lidocaine and/or Donepezil
- History of bleeding diathesis and/or gastrointestinal bleeding.
- Use of any medications that may affect sleep or breathing.
- A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- Substantial cigarette (\>5/day), alcohol (\>3oz/day) or use of illicit drugs.
- More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
- Deprived from sleep in the recent one week
- Desaturations to below 70% lasting greater than 10 seconds in duration per event in the sleep study (without Oxygen).
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02264353
Start Date
September 1 2014
End Date
May 1 2015
Last Update
August 8 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Diego
San Diego, California, United States, 92093