Brief Summary
This is a single center, single-arm, quantitative study evaluating the efficacy of the TatchSleep wireless sensor patches as a tool to aid in sleep apnea analysis as compared to an overnight PSG evaluation.
Brief Title
TatchSleep as a Tool to Aid in Sleep Apnea Analysis
Detailed Description
This is a multi-center, single-arm, quantitative study evaluating the effectiveness of the TatchSleep Pro wireless sensors as a tool to aid in sleep apnea diagnosis as compared to an overnight PSG evaluation.
Investigators will identify approximately 50 eligible patients who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study.
Patients will undergo their PSG test while simultaneously wearing 2 TatchSleep Pro patches and an FDA-cleared pulse oximeter compatible with and connected to the TatchSleep Pro system for a single night at the clinic. The same make and model of pulse oximeter will be used for all subjects. Patients will be observed overnight by trained sleep technicians who will setup the TatchSleep Pro device and collect the sleep data via the companion smartphone application.
A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events. Following the data collection, sleep data from PSG and TatchSleep Pro will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of TatchSleep Pro compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the TatchSleep Pro data to obtain an estimate of inter-rater reliability.
Investigators will identify approximately 50 eligible patients who have been recommended to receive an overnight PSG for the detection/evaluation of sleep apnea. After informed consent is obtained, a brief sleep-related medical history will be collected including relevant demographics. Females of childbearing potential will be asked to undergo a urine dipstick pregnancy test to determine their eligibility for inclusion in the study.
Patients will undergo their PSG test while simultaneously wearing 2 TatchSleep Pro patches and an FDA-cleared pulse oximeter compatible with and connected to the TatchSleep Pro system for a single night at the clinic. The same make and model of pulse oximeter will be used for all subjects. Patients will be observed overnight by trained sleep technicians who will setup the TatchSleep Pro device and collect the sleep data via the companion smartphone application.
A follow-up communication will be made with patients within 5 days after the sleep study to assess any adverse events. Following the data collection, sleep data from PSG and TatchSleep Pro will be scored by an independent qualified sleep technologist (the primary reader) to yield an analysis of the accuracy of TatchSleep Pro compared with the PSG signals. At least one and up to two additional readers (secondary readers) will score only the TatchSleep Pro data to obtain an estimate of inter-rater reliability.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Sleep Apnea
Sleep Disorder
Eligibility Criteria
Inclusion Criteria:
1. Be at least 18 years of age
2. Have a referral to the clinical site from a physician, to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
3. Be able to read, write, and speak English
4. Be willing and able to wear 3 TatchSleep patches, in conjunction with a polysomnogram, for a single night.
5. The patient must be able to sign a written informed consent form prior to the initiation of any study procedures. Adult patients unable to provide written informed consent on their own behalf will not be eligible for the study.
Exclusion Criteria:
1. Latex allergy
2. Morbidly obese patients (BMI\>39.5)
3. Females who are pregnant, trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
4. Women who are breast-feeding
5. Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.
1. Be at least 18 years of age
2. Have a referral to the clinical site from a physician, to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
3. Be able to read, write, and speak English
4. Be willing and able to wear 3 TatchSleep patches, in conjunction with a polysomnogram, for a single night.
5. The patient must be able to sign a written informed consent form prior to the initiation of any study procedures. Adult patients unable to provide written informed consent on their own behalf will not be eligible for the study.
Exclusion Criteria:
1. Latex allergy
2. Morbidly obese patients (BMI\>39.5)
3. Females who are pregnant, trying to get pregnant or who have a urine test positive for pregnancy on the day of the study
4. Women who are breast-feeding
5. Any known health condition that, in the opinion of the Investigator, would exclude the patient from participating in the study.
Inclusion Criteria
Inclusion Criteria:
1. Be at least 18 years of age
2. Have a referral to the clinical site from a physician, to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
3. Be able to read, write, and speak English
4. Be willing and able to wear 3 TatchSleep patches, in conjunction with a polysomnogram, for a single night.
5. The patient must be able to sign a written informed consent form prior to the initiation of any study procedures. Adult patients unable to provide written informed consent on their own behalf will not be eligible for the study.
1. Be at least 18 years of age
2. Have a referral to the clinical site from a physician, to complete an overnight polysomnogram test for sleep apnea detection or follow-up.
3. Be able to read, write, and speak English
4. Be willing and able to wear 3 TatchSleep patches, in conjunction with a polysomnogram, for a single night.
5. The patient must be able to sign a written informed consent form prior to the initiation of any study procedures. Adult patients unable to provide written informed consent on their own behalf will not be eligible for the study.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
120 Years
Minimum Age
18 Years
NCT Id
NCT04419714
Org Class
Industry
Org Full Name
Wesper Inc
Org Study Id
TCH-103
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Single Center, Single Arm, Quantitative Study Assessing Performance of TatchSleep as a Tool to Aid in Sleep Apnea Analysis
Primary Outcomes
Outcome Description
The correlation between AHI (3% desaturation criterion) measured by the TatchSleep Pro device and in-lab PSG will be assessed. Agreement between the two modalities will be analyzed using Bland-Altman analysis, and Pearson correlation coefficients will be calculated for AHI and ODI (3%). This outcome evaluates the concordance between TatchSleep Pro and PSG for key respiratory indices.
Outcome Measure
Correlation Between Polysomnography (PSG) and Tatch Apnea/Hypopnea Index (AHI)
Outcome Time Frame
12 hours
Secondary Outcomes
Outcome Description
Agreement in AHI severity classification (Normal, Mild, Moderate, Severe) between TatchSleep Pro and in-lab PSG was assessed using blinded scoring. Severity assignments from both devices were compared using percent agreement.
Outcome Time Frame
12 hours
Outcome Measure
Percent Agreement of AHI Severity Classification Between TatchSleep Pro and Polysomnography
Outcome Description
Agreement in AHI severity classification (Normal, Mild, Moderate, Severe) between TatchSleep Pro and in-lab PSG was assessed using blinded scorers. The level of agreement was quantified using the weighted Cohen's kappa coefficient.
Outcome Time Frame
12 hours
Outcome Measure
Agreement Between TatchSleep Pro and PSG on AHI Severity Using Cohen's Kappa
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
120
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Imran Ahmed
Investigator Email
iahmed@montefiore.org
Investigator Phone
718-920-4841
Categories Mesh Debug
Mental Health & Behavioral Research --- SLEEP WAKE DISORDERS
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Mental Health & Behavioral Research --- SLEEP DISORDERS, INTRINSIC
Mental Health & Behavioral Research --- DYSSOMNIAS
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
MeSH Terms
SLEEP APNEA SYNDROMES
SLEEP WAKE DISORDERS
APNEA
RESPIRATION DISORDERS
RESPIRATORY TRACT DISEASES
SLEEP DISORDERS, INTRINSIC
DYSSOMNIAS
NERVOUS SYSTEM DISEASES
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
MENTAL DISORDERS