Sleep Apnea, Sleep Disorder
Conditions
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.
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.
Interventions
DEVICETatchSleep
Wearable measurement device
Sponsors
Wesper Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Polysomnography (PSG) and Tatch Apnea/Hypopnea Index (AHI) | 12 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Agreement of AHI Severity Classification Between TatchSleep Pro and Polysomnography | 12 hours | 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. |
| Agreement Between TatchSleep Pro and PSG on AHI Severity Using Cohen's Kappa | 12 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TatchSleep Pro Test Arm TatchSleep: Wearable measurement device | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Deviation | 2 |
| Overall Study | Technical Fault | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TatchSleep Pro Test Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 48.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Correlation Between Polysomnography (PSG) and Tatch Apnea/Hypopnea Index (AHI)
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.
Time frame: 12 hours
Population: Subjects that used TatchSleep Pro while simultaneously undergoing a Polysomnography (PSG) sleep study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TatchSleep Pro Test Arm | Correlation Between Polysomnography (PSG) and Tatch Apnea/Hypopnea Index (AHI) | 0.95 correlation coefficient (r) |
Secondary
Agreement Between TatchSleep Pro and PSG on AHI Severity Using Cohen's Kappa
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.
Time frame: 12 hours
Population: Participants that simultaneously wore the TatchSleep Pro while undergoing a Polysomnography (PSG) sleep study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TatchSleep Pro Test Arm | Agreement Between TatchSleep Pro and PSG on AHI Severity Using Cohen's Kappa | 0.82 kappa |
Secondary
Percent Agreement of AHI Severity Classification Between TatchSleep Pro and Polysomnography
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.
Time frame: 12 hours
Population: Participants that simultaneously wore the TatchSleep Pro while undergoing a Polysomnography (PSG) sleep study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TatchSleep Pro Test Arm | Percent Agreement of AHI Severity Classification Between TatchSleep Pro and Polysomnography | 89 Percent Agreement |