Skiin-PSG Sleep Apnea

NCT06247878 | Recruiting

• 1 other identifier: PSG-Myant 157487
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the Skiin system for extraction of biological metrics during sleep based on the Skiin ECG and accelerometry data.

Conditions

Obstructive Sleep Apnea

Keywords

wearable electronic devices; digital health; sleep apnea

Outcome Measures

Primary Outcomes (1)

• Accuracy of Skiin system for detection of apnea/hypopnea compared to Polysomnography

  Apnea/hypopnea events identified in the Skiin system will be compared to Apnea/hypopnea events identified in the polysomnography system. Data will be categorized as true positive, false positive, false negative to calculate the sensitivity, specificity, PPV, NPV).

  Over one night, 8 to 12 hours total

Secondary Outcomes (4)

• Accuracy of Skiin system for detection of sleep duration compared to Polysomnography

  Over one night, 8 to 12 hours total

• Accuracy of Skiin system for estimation of breathing rate compared to Polysomnography

  Over one night, 8 to 12 hours total

• Accuracy of Skiin system for calculation of resting heart rate compared to Polysomnography

  Over one night, 8 to 12 hours total

• Accuracy of Skiin system for calculation of heart rate variability compared to polysomnography

  Over one night, 8 to 12 hours total

Study Arms (1)

Sleep apnea/hypopnea detection

Ability of Skiin underwear chest band in detecting sleep apnea or hypopnea will be tested against polysomnography.

Device: Skiin underwear chest band

Interventions

Skiin underwear chest band DEVICE

Participants will be asked to wear a skiin underwear chest band during a polysomnography test.

Sleep apnea/hypopnea detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit 200 individuals \> 18 years old, referred to a polysomnography test due to a diagnosed or suspected obstructive sleep apnea.

You may qualify if:

• Individuals referred to do a polysomnography
• Diagnosed or suspected obstructive sleep apnea (OSA)
• years old or more
• Understand and speak English enough to consent

You may not qualify if:

• Pregnant women
• Implanted defibrillator or pacemaker
• Absence of a garment fitting the participant's body
• An open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes

Sponsors & Collaborators

• Myant Medical Corp.: lead
• Jodha Tishon Inc: collaborator

Study Sites (1)

International Sleep Clinic WPSHC

Parry Sound, Ontario, P2A 3A4, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Colin Shapiro, MD

  Jodha Tishon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Shapiro, MD

CONTACT

416-551-829; colinshapiro@rogers.com

Naheed Hossain

CONTACT

647-291-5800; naheedkhossain@jodhatishon.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: February 2, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

CA (1)