Phase 4
N=44
The Impact of Arousal Threshold in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT02264353 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Apnea Hypopnea Index (AHI) — 50.0; 51.8 events/hour — p=0.576
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Donepezil (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index (AHI) |
50.0; 51.8 | 0.576 |
| SECONDARY Respiratory Arousal Threshold |
-18.0; -18.9 | 0.394 |
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 to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.
Eligibility Criteria
Inclusion Criteria
- Ages 18-70 years
- sleep study (with apnea hypopnea index>5)
- Diagnosis of obstructive sleep apnea
Exclusion Criteria
- 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 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).
Data sourced from ClinicalTrials.gov (NCT02264353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.