Trial Outcomes & Findings for TatchSleep as a Tool to Aid in Sleep Apnea Analysis (NCT NCT04419714)

NCT ID: NCT04419714

Last Updated: 2025-08-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

12 hours

Results posted on

2025-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Sleep Apnea Measurement Device (Test Arm) There is only one arm of this study. The arm includes adults that used the TatchSleep Pro device, which is a medical device that detects and measures sleep apnea.
Overall Study STARTED	53
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Sleep Apnea Measurement Device (Test Arm) There is only one arm of this study. The arm includes adults that used the TatchSleep Pro device, which is a medical device that detects and measures sleep apnea.
Overall Study Technical Fault	5
Overall Study Protocol Deviation	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Overall tested population was 53 but protocol deviation, equipment errors, and one withdrawal lead to 45 being analyzed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TatchSleep Pro Test Arm n=45 Participants TatchSleep: Wearable measurement device
Age, Categorical <=18 years	0 Participants n=5 Participants • Overall tested population was 53 but protocol deviation, equipment errors, and one withdrawal lead to 45 being analyzed
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants • Overall tested population was 53 but protocol deviation, equipment errors, and one withdrawal lead to 45 being analyzed
Age, Categorical >=65 years	13 Participants n=5 Participants • Overall tested population was 53 but protocol deviation, equipment errors, and one withdrawal lead to 45 being analyzed
Age, Continuous	48.8 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

Population: Subjects that used TatchSleep Pro while simultaneously undergoing a Polysomnography (PSG) sleep study

Outcome measures

Outcome measures
Measure	TatchSleep Pro Test Arm n=45 Participants This is the only arm tested in the study. Individuals within this arm were male and female participants, that were at least 18 years or older. Every participant wore the TatchSleep Pro device while simultaneously undergoing an in-lab PSG. TatchSleep: Wearable measurement device
Correlation Between Polysomnography (PSG) and Tatch Apnea/Hypopnea Index (AHI)	0.95 correlation coefficient (r) Interval 0.92 to 0.97

SECONDARY outcome

Timeframe: 12 hours

Population: Participants that simultaneously wore the TatchSleep Pro while undergoing a Polysomnography (PSG) sleep study

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 measures

Outcome measures
Measure	TatchSleep Pro Test Arm n=45 Participants This is the only arm tested in the study. Individuals within this arm were male and female participants, that were at least 18 years or older. Every participant wore the TatchSleep Pro device while simultaneously undergoing an in-lab PSG. TatchSleep: Wearable measurement device
Percent Agreement of AHI Severity Classification Between TatchSleep Pro and Polysomnography	89 Percent Agreement

SECONDARY outcome

Timeframe: 12 hours

Population: Participants that simultaneously wore the TatchSleep Pro while undergoing a Polysomnography (PSG) sleep study

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 measures

Outcome measures
Measure	TatchSleep Pro Test Arm n=45 Participants This is the only arm tested in the study. Individuals within this arm were male and female participants, that were at least 18 years or older. Every participant wore the TatchSleep Pro device while simultaneously undergoing an in-lab PSG. TatchSleep: Wearable measurement device
Agreement Between TatchSleep Pro and PSG on AHI Severity Using Cohen's Kappa	0.82 kappa Interval 0.7 to 0.94

Adverse Events

Medical Device: TatchSleep Pro: Single Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amir Reuvent

Wesper/Tatch

Phone: 5754482824

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place