Inspire Wear 1.5 External Accelerometer Observational Study
Study on Sleep Patterns Using Sensors
Stephanie Stahl
Primary Investigator
Brief description of study
This observational study is being conducted in order to obtain accelerometer-based signals of respiration, movement during sleep, time to fall asleep, and other physiological data to help develop the next generation of algorithms to improve Inspire device therapy. Data collected will be used to develop and validate algorithms to detect sleep onset and arousal. Such improvements are an essential element of Inspire Medical’s long-term vision for continued development of its OSA therapy.
Detailed description of study
The WEAR 1.5 study is a multicenter, prospective, non-randomized, observational, minimal-risk
study to acquire reference datasets that support Inspire Product Development efforts. Data will
be collected through external sensors measuring accelerometer inputs and compared to
standard approved sleep measurements in the form of the Sponsor provided Home Sleep Test
(HST) system and the Withings Sleep Mat.
Subjects must provide informed consent to participate in the study and will complete four (4)
nights of a home sleep study while wearing the Wear 1.5 external sensors and the Sponsor
provided HST within a 30 to 45 day window. Subjects will be asked to return the used Wear 1.5
devices to Inspire, along with a completed sleep report as provided, after each home sleep
study and receive verification of proper data collection prior to starting their next sleep study.
Sleep studies will be conducted on nights convenient for the study subject’s schedule, but
overall duration in the study will be dictated by the timeliness of the subject to return the Wear
1.5 external sensors each time and gain approval to begin the next night of data collection.
Additionally, subject data collected from the Withing Sleep Mat will be collected by the site one
time upon completion of the last home sleep test.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Sleep problems
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria
Subjects who meet all of the following criteria will be given consideration for inclusion in this
clinical investigation:
1. Have been implanted with the Inspire Upper Airway Stimulation Device, are 6 months
post-activation, are no longer titrating, and are still actively using their Inspire UAS at the
time of study enrollment;
2. Age 18 years or older at time of consent; and
3. Willing and capable of providing informed consent;
4. Have reliable WiFi in their home;
5. Smart phone capable of downloading the Withings Sleep Mat application (app) on their
phone; and
6. Valid email address where informed consent and study collected sleep data may be
shared
Exclusion Criteria
Subjects who meet any one of the following criteria will be excluded from this clinical investigation:
1. Pregnant; or
2. Participation in another clinical study (enrolled in any concurrent study) whose
investigational plan is judged to interfere or affect any of the measures of this study.
3. Subjects who are deemed unable to complete the requirements of the study testing,
including home sleep tests, application of the Wear 1.5 devices or the use of the Withings
Sleep Mat
This study investigates sleep patterns in individuals using external sensors to collect data on respiration, movement during sleep, and other physiological metrics. The purpose is to develop algorithms for improving therapy with the Inspire device, which is used to treat obstructive sleep apnea (OSA). An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.
Participants will undergo four nights of home sleep studies using external sensors and a home sleep test system. The study involves wearing the Wear 1.5 external sensors and collecting data through the Withings Sleep Mat. Participants must return the devices and complete sleep reports after each study night to ensure proper data collection.
- Who can participate: Participants must be 18 years or older, have been using the Inspire Upper Airway Stimulation Device for at least 6 months, and have stopped titrating. They must also have reliable WiFi, a smartphone capable of using the required app, and a valid email address.
- Study details: Participants will wear external sensors for four nights of home sleep studies and return the devices after each night. They must provide completed sleep reports to verify data collection before proceeding to the next study night.
