Status:
COMPLETED
Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study
Lead Sponsor:
Belun Technology Company Limited
Collaborating Sponsors:
Stanford University
Conditions:
Sleep-Disordered Breathing
Sleep Architecture
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly commercially available. However, the quality and reliability of the data from ELAM are unclear, compared with...
Eligibility Criteria
Inclusion
- Age between 18 to 80 years old. Ideally balanced for sex and age (18 to 80 years old)
- no more than 75% of subjects in one bin of: (male, female)
- no more than 50% of subjects in one age-group (18-29, 30-39, 40-49, 50-59, 60-80)
- Patients with OSA symptoms (snoring, excessive daytime sleepiness or witnessed apnea, etc.)
- Without any unstable medical or psychiatric co-morbidities that would be expected to interfere with the study.
- If taking any medication, must be on a stable dose of medication for a month
- Able to read and understand English
Exclusion
- Presence of any significant systemic or unstable medical condition which could lead to difficulty complying with the protocol, suicidality, current regular use of psychiatric medications, opiates, or thyroid medications, dementia, current substance abuse, post-traumatic or psychotic disorders, bipolar disorder; any significant neurologic disease, including possible and probable dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma, history of alcohol or substance use disorder within the past 2 years (DSM V criteria);
- If positive airway pressure (PAP) titration study or split night study (diagnostic and PAP titration study combined)
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06221124
Start Date
July 15 2020
End Date
June 12 2023
Last Update
January 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford Sleep Medecine Center
Redwood City, California, United States, 94063