Early Phase 1
Completed N=17
The Effect of Eszopiclone on the Arousal Threshold in Sleep Apnea Syndrome
Obstructive Sleep Apnea
Source: ClinicalTrials.gov NCT01102270 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Apnea Hypopnea Index — 24; 31 events per hour of sleep
Summary
The purpose of this study is to find out whether taking eszopiclone (Lunesta) changes the breathing effort required to briefly wake people with obstructive sleep apnea from sleep (respiratory arousal threshold). We would like to see if taking eszopiclone can reduce the severity of obstructive sleep apnea in some people (those that have a low respiratory arousal threshold; i.e. wake up easily to respiratory stimuli).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea Hypopnea Index |
24; 31 | — |
| SECONDARY Arousal Threshold |
-18; -14 | — |
| SECONDARY Nadir Overnight Oxygen Saturation |
80; 80 | — |
| SECONDARY Sleep Duration |
6.8; 5.4 | — |
Eligibility Criteria
Inclusion Criteria
- 18-64 years old
- Untreated obstructive sleep apnea
Exclusion Criteria
- Nadir SaO2 <70% on a baseline PSG
- Medications known to affect either sleep, breathing or muscle activity
- Major co-morbidities apart from sleep apnea
- Allergy to lidocaine, oxymetazoline HCl, or eszopiclone
- Women who are pregnant
Data sourced from ClinicalTrials.gov (NCT01102270). 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.