Clinical Evaluation of a Wearable Sleep Diagnosis Technology

Obstructive Sleep Apnea Clinical Trial

Official title:

Clinical Evaluation of a Wearable Sleep Diagnosis Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544086
• Other study ID #: 225818
• Secondary ID: 225818
• Status: Completed
• Start date: July 10, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: December 2020
• Source: Acurable Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.

Description:

The clinical investigation will be performed at the Royal Free London Hospital. Physiological signals will be pseudo-anonymized and only viewed by the research team.

The Study will involve patients who will have been referred for diagnosis of sleep apnoea, will aim to determine AcuPebble's positive and negative predictive ratios, sensitivities as specificities. Likelihood ratios for diagnosis of sleep apnoea. Clinical experts will determine patients' diagnostic information using the current diagnostic standards. AcuPebble will also generate diagnostic results independently and automatically. Both set of results will be subsequently compared and the relevant performance metrics listed above will be determined.

Consecutive patients referred for sleep study will be recruited to the study. Patients that are willing to participate will be consented on the day of their sleep study and sent home with both - the Trusts usual multichannel polygraphy and the Acupebble.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 15, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.

Exclusion Criteria:

• Age under 18 or over 70 years.

• Subjects who are not fluent in English, or who have special communication needs.

• Known allergy to the adhesive dressing.

• Subjects with physical or mental impairments who would not be able to use the new technology on their own.

• Subjects with very loose/saggy skin in the neck area which would unavoidably result on
• AcuPebble swinging if moving the neck.

• Subjects with pacemakers.

• exclude patients who have any type of implanted electronic devices (these include patients in ICDs and left ventricular assist devices and loop recorders).

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United Kingdom	Royal Free Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Acurable Ltd.	Royal Free Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivities and Specificities for diagnosis of sleep apnoea studies	Sensitivities and Specificities for diagnosis of sleep apnoea studies	6 months