Obstructive Sleep ApneaDISCRETE AFNCT07220525
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
A study testing HGNS Use Randomized Instructions in people with Obstructive Sleep Apnea and Premature Ventricular Contraction (PVC), run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC), Atrial Fibrillation (AF)
- What is being tested?
- HGNS Use Randomized Instructions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are age 21 years or older
- Have a HGNS device implanted for obstructive sleep apnea and followed up at UCSF Health
- Are willing to abstain from using the upper airway stimulation device for no more than two consecutive days as instructed over the 14-day trial period
- Able and willing to provide written informed consent
Who cannot join
- Currently pregnant or trying to get pregnant
- Are currently taking class 1 or 3 anti-arrhythmic medications
- Have a history of permanent AF or expected to have continuous AF throughout the study period
- Have congenital heart disease
- Ventricular pacing >40%
- Are unable to read or sign to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSF Medical Center at Parnassus
San Francisco, California, 94143
Gregory Marcus, MD, MAS, 415-476-5706, greg.marcus@ucsf.edu
Gregory Marcus, MD, MAS
About this study
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.
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC), Atrial Fibrillation (AF), Premature Atrial Contraction
- Being tested
- HGNS Use Randomized Instructions
- Keywords
- Sleep Apnea, Hypoglossal Nerve Stimulation Device, Atrial Fibrillation, Upper Airway Stimulation, Premature Atrial Contraction, Premature Ventricular Contraction
- Medical subject headings
- Sleep Apnea, Obstructive, Ventricular Premature Complexes, Atrial Fibrillation, Atrial Premature Complexes, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGNS Use Randomized InstructionsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HGNS Use Randomized Instructions |
| 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. Receives: Device: HGNS Use Randomized Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ectopic beats
Daily number of ectopic beats as recorded with the adhesive heart monitor
Measured: 24-hour time period
Secondary outcomes (3)
Premature Atrial Contractions (PACs)
Daily number of PACs as recorded with the adhesive heart monitor
Measured: 24-hour time period
Premature Ventricular Contractions (PVCs)
Daily number of PVCs as recorded with the adhesive heart monitor
Measured: 24-hour time period
Atrial Fibrillation (AF)
Daily presence of AF ≥30 seconds as recorded with the adhesive heart monitor
Measured: 24-hour time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start15 Dec 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Marcus, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220525
- Sponsor's protocol ID
- 25-43785
- Acronym
- DISCRETE AF
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07220525
- Acronym / sponsor ID
- DISCRETE AF / 25-43785
- Conditions
- Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC), Atrial Fibrillation (AF), Premature Atrial Contraction
- Keywords
- Sleep Apnea, Hypoglossal Nerve Stimulation Device, Atrial Fibrillation, Upper Airway Stimulation, Premature Atrial Contraction, Premature Ventricular Contraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HGNS 'Off' Case-Crossover Arm | Experimental | Device: HGNS Use Randomized InstructionsOn 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 | Device: HGNS Use Randomized InstructionsOn 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are age 21 years or older
- Have a HGNS device implanted for obstructive sleep apnea and followed up at UCSF Health
- Are willing to abstain from using the upper airway stimulation device for no more than two consecutive days as instructed over the 14-day trial period
- Able and willing to provide written informed consent
Key exclusion criteria (6 listed)
- Currently pregnant or trying to get pregnant
- Are currently taking class 1 or 3 anti-arrhythmic medications
- Have a history of permanent AF or expected to have continuous AF throughout the study period
- Have congenital heart disease
- Ventricular pacing >40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGNS Use Randomized InstructionsIn 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. | Device | HGNS 'Off' Case-Crossover Arm, HGNS 'On' Case-Crossover Arm |
Primary outcome
Ectopic beats
Time frame: 24-hour time period
Daily number of ectopic beats as recorded with the adhesive heart monitor
3 secondary outcomes
Premature Atrial Contractions (PACs)
Time frame: 24-hour time period
Premature Ventricular Contractions (PVCs)
Time frame: 24-hour time period
Atrial Fibrillation (AF)
Time frame: 24-hour time period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Marcus, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HGNS Use Randomized Instructions in people with Obstructive Sleep Apnea and Premature Ventricular Contraction (PVC), run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Oo, BS (415-476-4999, hannah.oo@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ectopic beats (time frame: 24-hour time period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.