MedPath

An exploratory study to evaluate relationship between interoception and sleep quality

Not Applicable
Registration Number
CTRI/2022/10/046183
Lead Sponsor
Turtle Shell Technologies Private Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1. Healthy volunteers of ages >20 years and <70 years within weight range 40 kg - 125 kg

2. Provide informed consent for the participation in an overnight study at the sleep lab.

Exclusion Criteria

1. Subject has any history of medical and sleep disorder syndrome, drug or alcohol dependence and not under any medication as assessed by personal interviews.

2. Volunteers of ages <20 years and >70 years outside of the weight range 40 kg - 120 kg

3. Volunteers with disturbed sleep one night before the actual sleep recordings

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Validation of Dozee sleep staging, breathing rate, heart rate variability and snore detection to sleep lab polysomnography-based assessment. <br/ ><br>2. Evaluating the impact of environment specifically light, sound and temperature on sleep quality <br/ ><br>3. Evaluation of macrosleep architecture parameters such sleep stages duration, sleep stage percentage, sleep efficiency etc. <br/ ><br>4. Evaluation of EEG dynamics (the synchrony, frequency, spectrum, amplitude, coherence and topography of the frequency bands- alpha, beta, theta, delta and gamma) associated with sleep states. <br/ ><br>5. Evaluation of biological level of melatonin and cortisol before and after the sleep.Timepoint: At Baseline
Secondary Outcome Measures
NameTimeMethod
ATimepoint: NA
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