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OpenTrials
Completed

NCT Number: NCT06320795

Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device

This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of obstructive sleep apnea (OSA) syndrome in subjects with suspected diagnosis of sleep disorders.

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Key information

Conditions

OSA

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatorio del Sonno- Istituto Auxologico Italiano IRCCS - Ospedale San Luca

Milan, 20149, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are able to understand the nature of the study and to give free informed consent
  • Must be over 20 and referred by medical staff for an overnight assessment for suspected sleep apnea

Exclusion criteria

  • Pregnancy
  • Pacemaker wearer
  • Allergies to any material of the device

Treatment and study plan

SOUNDI

Device

Continuous monitoring of vital signs for diagnosis and follow-up of sleep-disordered breathing in adults.

Primary outcomes

  1. To evaluate the accuracy of the clinical diagnosis of OSA

    Time frame: 6 Months

    To evaluate the accuracy of the clinical diagnosis of OSA assisted by the home sleep study with SOUNDI against the clinical diagnosis assisted by the PSG as the reference standard.

  2. To evaluate the agreement between the Apnea Hypopnea Index (AHI) from the home sleep study with SOUNDI and the home sleep study with polysomnography (PSG)

    Time frame: 6 Months

    To evaluate the agreement between the AHI from the home sleep study with SOUNDI and the home sleep study with PSG in patients being referred to sleep clinics with suggestive OSA symptoms.

Secondary outcomes

  1. Patient satisfaction

    Time frame: Day 1

    Patient satisfaction were determined by interview.

Sponsors and collaborators

Lead sponsor

Biocubica srl

Industry

Registry information

Official study title

Studio Prospettico Per la Validazione Clinica Del Dispositivo Medico Indossabile Soundi

Acronym: SOUNDI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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