Phase 4
Completed N=14
Sleep and Breathing in the General Population - Chemical Stimuli
Source: ClinicalTrials.gov NCT04720547 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcomePrimary: The Central Apnea-hypopnea Index — 14.1; 29.9 events per hour
◆ Published Evidence
Emerging
12citations · ~4 / year
Effect of Zolpidem on nocturnal arousals and susceptibility to central sleep apnea.
Summary
Central sleep apnea (CSA) is a common condition and its treatment remains elusive. The focus of this proposal is to identify the role of the physiologic path involving cortical arousals in CSA by decreasing arousal frequency using the pharmacological agent zolpidem. The goal is to identify the acute effects of administering zolpidem on sleep and respiratory outcomes, and subsequently, its effect on the severity of CSA and propensity to develop CSA. This study will shed light on the mechanisms underlying CSA that involve cortical arousals and will guide future therapeutic interventions for CSA.
Linked Publications
-
Effect of Zolpidem on nocturnal arousals and susceptibility to central sleep apnea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Central Apnea-hypopnea Index |
14.1; 29.9 | — |
| PRIMARY Respiratory Arousal Index |
23.3; 39.7 | — |
| SECONDARY CO2 Reserve |
-0.63; -0.44 | — |
| SECONDARY Controller Gain |
2.39; 3.95 | — |
| SECONDARY Stead-State Plant Gain (mmHg |
4.78; 5.27 | — |
| SECONDARY Respiratory Arousal Threshold |
-8.72; -8.25 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)>15/hour with CAHI>5/hour, will be included in the experiments.
Exclusion Criteria
- less than 18 years old
- pregnant or breastfeeding female
- have severe respiratory disease that require to be on oxygen
- recent health event that may affect the ability to participate in the study,
- Body Mass Index (BMI) is >40 kg/m2
- significant insomnia
- mental instability
- recent health event that may affect sleep
- if at any time the principal investigator (PI) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study
Data sourced from ClinicalTrials.gov (NCT04720547) 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.