Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Whereas the available evidence mostly supports chronic sleep disruption as a risk factor for incident AF, less is known about the near-term risk of a discrete atrial fibrillation (AF) episode following a night of disrupted or poor-quality sleep. This prospective, randomized, case-crossover study aims to examine the acute effects of sleep disruption on clinically relevant cardiac ectopy pertinent to AF.
One hundred patients aged 21 years or older who have a hypoglossal nerve stimulation (HGNS) device implanted for obstructive sleep apnea, without a history of permanent AF, not on Class 1 or 3 antiarrhythmic medications and willing to participate in the study, will be randomized to "off-on" versus "on-off" periods (where "off" is turning off the HGNS device for one night and "on" is turning on the HGNS device), assuring no more than two consecutive days of either device use or not, over the ensuing 14 days. Participants will be fitted with an automatically recording electrocardiographic monitor. The primary endpoint will be the daily number of cardiac ectopic beats, and secondary endpoints: daily number of PACs, daily number of PVCs, and daily presence versus absence of AF episodes ≥ 30 seconds. Primary analyses will employ intention-to-treat principles, examining randomization assignment as the primary predictor.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HGNS 'Off' Case-Crossover Arm | Experimental | On a given day of the 14-day study period, participants may be randomly assigned to turn off/not use their HGNS device during that night of sleep. Participants will not receive the same randomization assignment more than two consecutive days in a row. |
|
| HGNS 'On' Case-Crossover Arm | Experimental | On a given day of the 14-day study period, participants may be randomly assigned to turn on/use their HGNS device during that night of sleep. Participants will not receive the same randomization assignment more than two consecutive days in a row. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGNS Use Randomized Instructions | Device | In this intervention assignment, participants will be instructed to turn off/not use their HGNS device during that night of sleep. HGNS 'on': In this intervention assignment, participants will be instructed to turn on/use their HGNS device during that night of sleep. |
| Measure | Description | Time Frame |
|---|---|---|
| Ectopic beats | Daily number of ectopic beats as recorded with the adhesive heart monitor | 24-hour time period |
| Measure | Description | Time Frame |
|---|---|---|
| Premature Atrial Contractions (PACs) | Daily number of PACs as recorded with the adhesive heart monitor | 24-hour time period |
| Premature Ventricular Contractions (PVCs) | Daily number of PVCs as recorded with the adhesive heart monitor |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah Oo, BS | Contact | 415-476-4999 | hannah.oo@ucsf.edu | |
| Bella Peña, BA | Contact | 415-502-3053 | bella.pena@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gregory Marcus, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center at Parnassus | Recruiting | San Francisco | California | 94143 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2025 | Oct 22, 2025 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D018879 | Ventricular Premature Complexes |
| D001281 | Atrial Fibrillation |
| D018880 | Atrial Premature Complexes |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 24-hour time period |
| Atrial Fibrillation (AF) | Daily presence of AF ≥30 seconds as recorded with the adhesive heart monitor | 24-hour time period |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |