Clinical trial NCT06221124: Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study
Official title: Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-Disordered Breathing
Sleep Architecture
Lead sponsor: Belun Technology Company Limited
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2024-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 polysomnography (PSG), which is the gold-standard sleep assessment method. Thus, combining ELAM with PSG will validate ELAM and improve its clinical and research utilization.

The investigators propose to conduct this study to validate ELAM device for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab PSG measures of Sleep-Disordered Breathing (SDB) and sleep architecture in adults with obstructive sleep apnea (OSA) symptoms.

The investigators propose to recruit a total of 40 participants with symptoms of OSA. The overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture will be validated by using PSG analysis as a gold standard.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Validation with gold-standard polysomnography (PSG) recording
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Sleep Medecine Center
state: California
Study officials:
References: