The Impact of Arousal Threshold in Obstructive Sleep Apnea

Completed · Phase 4 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT02264353

Run by

University of California, San Diego

People needed

44

Starts

2014-09-01

Expected to finish

2015-05-01

Last updated by the study team

2019-08-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-70 years
• sleep study (with apnea hypopnea index>5)
• Diagnosis of obstructive sleep apnea

You may not qualify if…

• 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).

Where it is running

• University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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