Testing a wearable device for diagnosing sleep apnea
Evaluación clínica de Una tecnología Ambulatoria Para diagnóstico Del sueño
This study is testing a new wearable device to see if it can accurately diagnose sleep apnea compared to traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Acurable Ltd. Industry-sponsored |
| Locations | 1 site (Seville) |
| Trial ID | NCT04028011 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a new wearable device designed to diagnose obstructive sleep apnea by comparing its effectiveness to traditional diagnostic methods such as multi-channel polygraphy and polysomnography. Participants will wear the device while undergoing these established tests to assess its accuracy and reliability. The study aims to provide a more accessible and convenient option for diagnosing sleep apnea, potentially improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have been referred to a sleep clinic due to suspected sleep apnea.
Not a fit: Patients who are not fluent in Spanish, have communication needs, or possess certain physical conditions that prevent them from using the device may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could offer a more convenient and accurate method for diagnosing sleep apnea, leading to timely treatment.
How similar studies have performed: Other studies have shown promise in using wearable technology for sleep apnea diagnosis, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea. * patients between the age of 18 yo and 80 yo Exclusion Criteria: * who are not fluent in Spanish, or who have special communication needs. * Known allergy to the adhesive dressing. * patients with physical or mental impairments who would not be able to use the new technology on their own. * patients with very loose/saggy skin in the neck area which would unavoidably result on AcuPebble swinging if moving the neck. * patients with pacemakers or who have any type of implanted electronic device
Where this trial is running
Seville
- Hospital Virgen Macarena Sevilla — Seville, Spain (Recruiting)
Study contacts
- Principal investigator: Jesus Fernando Sanchez Gomez, MD — Hospital Universitario Virgen Macarena
- Study coordinator: Orsina Dessi, MEng
- Email: orsina@acurable.com
- Phone: +447721 877020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.