Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05252130

Enrollment

Registered

2022-02-23

Start date

2021-12-22

Completion date

2022-02-10

Last updated

2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pathology

Brief summary

Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison with the conventional 3M Littmann stethoscope

Detailed description

The enrolled population will include adults with a history of heart and lung complications. The enhanced sound quality of the electronic stethoscope and its non-inferiority to the traditional/conventional 3M Littmann stethoscope will be assessed through auscultation examination of every patient by a health professional (consultant, medical resident, and house officer) with both the electronic stethoscope and 3M Littmann/traditional/conventional stethoscope

Interventions

DEVICENoaScope

Smart digital stethoscope

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Ages: 18 years or older (male and female) * Hospital admitted or Out Patient Department * Written consent provided

Exclusion criteria

* Age \<18 * ICU admitted * Written consent not provided

Design outcomes

Primary

Measure	Time frame	Description
Correctly identified abnormal heart and lung sounds by doctors using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III.	1 month	Each patient will receive two auscultation examinations: one with NoaScope and another with 3M™️ Littmann®️ Classic III. The investigators will determine the clinical feasibility and non-inferiority of NoaScope to the FDA-approved 3M™️ Littmann®️ Classic III from auscultation findings (heart and lungs) by doctors (holding varied levels of clinical expertise). Doctors will examine each patient using two stethoscopes: NoaScope and 3M™️ Littmann®️ Classic III. The investigators will also measure inter and intra observer agreement by the Kappa index with the help of a questionnaire. Kappa values \< 0.8 means weak to moderate level of agreement and Kappa values between 0.8 - 1.0 would mean strong level of agreement.
The measurement of sound quality in a clinical setting by means of an MOS scale on a questionnaire.	1 month	The investigators will measure sound quality on a mean opinion score scale with values ranging form 1 (bad) to 5 (excellent).

Secondary

Measure	Time frame	Description
Difference in performance between subgroups of doctors based on clinical experience.	1 month	This will be estimated as a proportion difference of correctly identified heart and lung sounds for each doctor subgroup.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026