Trial Outcomes & Findings for PMP-300E (Smart Watch): Portable Monitoring Device Study (NCT NCT01364740)

NCT ID: NCT01364740

Last Updated: 2017-01-27

Results Overview

Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: One night
• Results posted on: 2017-01-27

Participant Flow

Patients were recruited through the patient population at the Stanford Sleep Medicine Center

Participant milestones

Measure	SmartWatch PMP-300E Investigational device Smart Watch PMP-300E to measure sleep-related breathing was tested against conventional gold-standard In-Lab Polysomnography (sleep studies) Smart Watch PMP-300E: Data collected from a Level 3 portable monitoring device In-lab Polysomnography: Data collected from Type I In-Lab Polysomnography
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PMP-300E (Smart Watch): Portable Monitoring Device Study

Baseline characteristics by cohort

Measure	PMP-300E, In-Lab PSG n=10 Participants PMP-300E, In-Lab PSG: PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study) PMP-300E: Data collected from Level 3 device In-lab PSG: Data collected from Type I In-Lab Polysomnography
Age, Customized Men	54.3 years STANDARD_DEVIATION 15.46 • n=5 Participants
Age, Customized Women	56.8 years STANDARD_DEVIATION 14.24 • n=5 Participants
Gender Female	4 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants
Body Mass Index Men	29.5 kg/m^2 STANDARD_DEVIATION 9.54 • n=5 Participants
Body Mass Index Women	30.8 kg/m^2 STANDARD_DEVIATION 11.76 • n=5 Participants
Epworth Sleepiness Scale score	6.9 units on a scale STANDARD_DEVIATION 5.61 • n=5 Participants

PRIMARY outcome

Timeframe: One night

Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.

Outcome measures

Measure	PMP-300E, In-Lab Polysomnography n=10 Participants Patient data from one night with the PMP-300E, compared to In-Lab PSG data
AHI PMP-300E	19.2 events/hour Standard Deviation 14.50
AHI In-Lab PSG	19.3 events/hour Standard Deviation 14.5

SECONDARY outcome

Timeframe: One night

Number of events/hour of sleep

Outcome measures

Measure	PMP-300E, In-Lab Polysomnography n=10 Participants Patient data from one night with the PMP-300E, compared to In-Lab PSG data
Apnea Index PMP-300E	7.7 events/hour Standard Deviation 11.06
Apnea Index In-Lab PSG	9.8 events/hour Standard Deviation 13.32

SECONDARY outcome

Timeframe: One night

Number of events/hour of sleep. Hypopneas scored without EEG arousals.

Outcome measures

Measure	PMP-300E, In-Lab Polysomnography n=10 Participants Patient data from one night with the PMP-300E, compared to In-Lab PSG data
Hypopnea Index PMP-300E	8.8 events/hour Standard Deviation 4.96
Hypopnea Index In-Lab PSG	14.1 events/hour Standard Deviation 19.0

SECONDARY outcome

Timeframe: One night

Mean oxygen saturation

Outcome measures

Measure	PMP-300E, In-Lab Polysomnography n=10 Participants Patient data from one night with the PMP-300E, compared to In-Lab PSG data
Oxygen Saturation PMP-300E	94.8 percent Standard Deviation 2.10
Oxygen Saturation In-Lab PSG	95.0 percent Standard Deviation 2.11

OTHER_PRE_SPECIFIED outcome

Timeframe: one night

Questionnaire consisting of multiple questions, scored as 1 = disagree completely to 5 = agree completely, revealed the following mean scores

Outcome measures

Measure	PMP-300E, In-Lab Polysomnography n=10 Participants Patient data from one night with the PMP-300E, compared to In-Lab PSG data
Attitude Toward Device Use Questionnaire Scores Confident in using device at home	4.3 units on a scale Standard Deviation 0.82
Attitude Toward Device Use Questionnaire Scores Confident in applying nasal cannula on own	4.4 units on a scale Standard Deviation 0.84
Attitude Toward Device Use Questionnaire Scores confident in applying finger probe on own	4.9 units on a scale Standard Deviation 0.32
Attitude Toward Device Use Questionnaire Scores Can read window display without difficulty	3.9 units on a scale Standard Deviation 0.99
Attitude Toward Device Use Questionnaire Scores Can hear the on/off beep without difficulty	3.8 units on a scale Standard Deviation 1.03
Attitude Toward Device Use Questionnaire Scores Can strap on chest belt without difficulty	4.5 units on a scale Standard Deviation 0.71
Attitude Toward Device Use Questionnaire Scores Importance of finding out more about own sleep	4.8 units on a scale Standard Deviation 0.42
Attitude Toward Device Use Questionnaire Scores Bed partner is a restless sleeper or loud snorer	1.2 units on a scale Standard Deviation 1.40

Adverse Events

PMP-300E, In-Lab Polysomnography

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

Clete A. Kushida, MD, PhD

Stanford University

Phone: 650-721-7560

Email: clete@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place