The Impact of Arousal Threshold in Obstructive Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | September 2014 |
| End Date: | May 2015 |
The Impact of Arousal Threshold in Obstructive Sleep Apnea: Donepezil's Effects on the Arousal Threshold and on the Apnea Hypopnea Index
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.
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.
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 approved by the U.S. Food and Drug Administration
(FDA) for the treatment of symptoms of Alzheimer's disease.
Eligible participants will undergo overnight polysomonography as described below and will
receive either donepezil (10 mg immediately prior to sleep) or placebo (in random order)
followed roughly 14 days later with placebo or donepezil. This aim will allow us to test the
impact of donepezil on the apnea hypopnea index. The study plans to enroll approximately 30
subjects.
The change in apnea hypopnea index as well as arousal thresholds/upper airway mechanics will
be compared in the donepezil groups with the placebo group.
effects on the arousal threshold and on the apnea hypopnea index.
Donepezil is a cholinesterase inhibitor approved by the U.S. Food and Drug Administration
(FDA) for the treatment of symptoms of Alzheimer's disease.
Eligible participants will undergo overnight polysomonography as described below and will
receive either donepezil (10 mg immediately prior to sleep) or placebo (in random order)
followed roughly 14 days later with placebo or donepezil. This aim will allow us to test the
impact of donepezil on the apnea hypopnea index. The study plans to enroll approximately 30
subjects.
The change in apnea hypopnea index as well as arousal thresholds/upper airway mechanics will
be compared in the donepezil groups with the placebo group.
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 <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).
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