Viewing Study NCT06625697



Ignite Creation Date: 2024-10-26 @ 3:41 PM
Last Modification Date: 2024-10-26 @ 3:41 PM
Study NCT ID: NCT06625697
Status: RECRUITING
Last Update Posted: None
First Post: 2024-09-25

Brief Title: Mindfulness Training and Respiration Biosignal Feedback - Study 1
Sponsor: None
Organization: None

Study Overview

Official Title: Mindfulness Training and Respiration Biosignal Feedback - Study 1
Status: RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The goal of this research is to develop a new breathing feature on the meditation app Equa to help young adults who are distressed understand their physiological responses and mindfulness skill development during meditation

Our main aims are to build an algorithm that can use respiration signals ie breathing to

Give feedback about how participant physiology is changing during guided lessons on the meditation app Equa
Measure how much participant mindfulness skills are improving

Participants will

Complete a survey about demographics their thoughts and feelings before and after the mindfulness meditation program
Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded
Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills
Detailed Description: Investigators will recruit young adults to participate in a study to examine the effectiveness of respiration dynamics during meditation through phone motion data and microphones within headphones Interested participants who contact us will be screened on study inclusionexclusion criteria 1 aged 18-30 years 2 indicate moderate to high levels of psychological distress over the past two weeks 3 interested in coming on site to complete 14 smartphone guided mindfulness meditation training units 4 willing to wear physiological monitoring equipment and provide ratings of their training experience 5 Not currently pregnant and 6 no current or previous diagnosis of psychosis or schizophrenia

Participants are told they are going to participate in a study that focuses on monitoring physiological responses during meditation At the start of the study participants will complete questions via an online survey focused on demographics prior meditation experience perceived stress loneliness anxiety affect mindfulness and well-being to understand factors that may relate to their respiration data meditation practice their perceived mindfulness characteristics

Participants will complete a few brief questionnaires before and after each mindfulness practices to understand potential changes in mindfulness Eg levels of equanimity sensory clarity and concentration Participant physiological data will be recorded Eg breathing sounds and motion data via smartphones and wireless headphones to track respiration dynamics Additionally the sensory shirt made by Hexoskin Smart Sensors AI will also continuously measure respiration via two respiratory inductive plethysmography RIP sensors The Hexoskin shirt also tracks motion via a three-axis accelerometer These breathing and motion measures will enable investigators to better understand mindfulness measures Eg concentration clarity and equanimity during meditation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None