Phase 4
Completed N=44
The Impact of Arousal Threshold in Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT02264353 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Apnea Hypopnea Index (AHI) — 50.0; 51.8 events/hour — p=0.576
◆ Published Evidence
Established
28citations · ~3 / year
The Effect of Donepezil on Arousal Threshold and Apnea-Hypopnea Index. A Randomized, Double-Blind, Cross-Over Study.
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.
Linked Publications (2)
-
The Effect of Donepezil on Arousal Threshold and Apnea-Hypopnea Index. A Randomized, Double-Blind, Cross-Over Study.
-
Is there a threshold that triggers cortical arousals in obstructive sleep apnea.
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 |
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) and the linked publication. 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. Informational only — not medical advice.