- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665844
Smart Sleep In-home Validation Extension Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study procedures
Visit 1 (Screening) Procedures (up to 2 hours):
Participants will be asked to report to the research site for a daytime visit. A detailed interview will be performed verifying eligibility criteria, as well as a review of work and non-work schedules. After a full explanation of the protocol and after all the participants' questions have been answered, they will be asked to sign the consent form.
Participants will complete the following baseline information:
Demographics Questionnaires Medical History Questionnaire Review of Current Medications Height, Weight, Head Measurements Cognitive Assessment training
Once eligibility confirmed, participants will be trained in the use of the SmartSleep device, including pairing and syncing of the SleepMapper app
Home Use (weeks 1-4) All participants will be asked to wear the device consecutively every night. The anticipated study participation is expected to be one month of use (+ 2 weeks based on participant schedule). All participants will wear the device for 1 week of baseline use. Post one week of use (+/- 2 days), participants will the active mode. Participants will continue nightly home use of the SmartSleep with boost enabled for the next 3 weeks.
Participants will be asked to complete the cognitive testing daily after wake up. Cognitive tests should be performed at the same time each morning following the same routine.
Participants will be asked to complete the a question twice daily.
During the study if a participant's medical history or medication changes, they will be asked to inform the study team. Participants will be asked during the course of the study if they experience any discomfort, red marks, etc.
Study completion (final visit) Participants will be asked to return to the lab for a final study visit. They will be asked to bring their study materials.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Lehigh Acres, Florida, United States, 33971
- Florida Lung & Sleep Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Able to provide informed consent
- Live in the US
- Able to read, write and speak English
- Adult volunteers aged 21-50
- Smartphone owner (iOS 9+ or Android 5.0+ OS)
- Access to home Wi-Fi for syncing of SmartSleep data and cognitive testing
- Working full time schedule [Note: Full time is considered a 32 hour work week start time at 7am or later]
Suffer from short sleep due to lifestyle
- Gets less than 7 hours of sleep at least 3 days a week (via self-report)
- Get at least 5 hours of sleep per night 7 nights a week (via self-report)
- Gets 1 extra hour of sleep on the weekends (via self-report of extended nightly sleep or daytime nap)
Exclusion Criteria:
- Individuals who self-report severe contact dermatitis or an allergy to silver
Diagnosed as having any of the following conditions (via self-report):
- Sleep Apnea
- Insomnia
- Restless legs syndrome
- Parasomnia
- Epilepsy/Seizures
- Diagnosed as having any major organ system disease such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease, respiratory failure or respiratory insufficiency, or patients requiring oxygen therapy (via self-report)
- High Risk of Obstructive Sleep Apnea (OSA) based on Questionnaire
- Daily caffeine intake > 650 mg
- History of moderate hearing loss (via self-report)
- Currently working night shift or rotating shift
- Head circumference <54 cm (21 in) or >66 cm (26 in)
- Individuals who self-report taking longer than 30 minutes more than 3 times a week to fall asleep once they turn lights off
- Individuals who self-report regularly taking sleeping pills (more than once per week), including prescription or over the counter (OTC) pills such as Ambien, Tylenol PM or Zzzquil
- Pregnant (via self-report)
- Employee of Philips or spouse of a Philips employee
- Employee (or spouse of an employee) of a company that designs, sells, or manufactures sleep-related products
- Not able to comply with study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: SmartSleep Boost Off
Participants wear the device for baseline data collection in boost off mode.
There is no intervention.
This is known as SmartSleep Boost Off mode.
|
SmartSleep device can be configured to two different settings.
SmartSleep Boost Off provides no audio tones.
|
ACTIVE_COMPARATOR: SmartSleep Boost On
Participants wear the device for 3 weeks in boost on mode.
This is known as SmartSleep Boost On mode.
|
SmartSleep device can be configured to two different settings. SmartSleep Boost On setting provides soft audio tones during the night. It's a non-invasive portable light weight device designed to stimulate deep slow wave sleep (SWS). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effects of the auditory stimulation delivered by the SmartSleep device in adults with shortened sleep schedules due to lifestyle as determined by changes in the cumulative (CSWA) or average slow-wave activity.
Time Frame: 4 weeks
|
Efficacy will be evaluated based on the average of seven nights of use collecting baseline data compared to the average of twenty one nights of active SmartSleep, while in the home setting.
SWA accumulation over Non-Rapid Eye Movement (NREM) sleep (CSWA) will be analyzed for each night in the active condition using as reference the average CSWA across baseline nights.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in performance of the Matrix reasoning task (MRT) correlated to the changes in CSWA over the trial period.
Time Frame: 4 weeks
|
Performance of the MRT during baseline and active use weeks of the SmartSleep Device will be compared to changes in CSWA over the trial period.
|
4 weeks
|
Change in performance of the Digital Symbol Substitution Task (DSST) correlated to the changes in CSWA over the trial period.
Time Frame: 4 weeks
|
Performance of the DSST during baseline and active use weeks of the SmartSleep Device will be compared to changes in CSWA over the trial period.
|
4 weeks
|
Change in performance of the Psychomotor Vigilance Testing -Brief (PVT) correlated to the changes in CSWA over the trial period.
Time Frame: 4 weeks
|
Performance of the PVT during baseline and active use weeks of the SmartSleep Device will be compared to changes in CSWA over the trial period.
|
4 weeks
|
Change in sleepiness/alertness as measured by a 7 point scale correlated to the changes in CSWA over the trial period.
Time Frame: 4 weeks
|
Change in sleepiness/alertness as measured by a 7 point scale during baseline and active use weeks of the SmartSleep Device will be compared to changes in CSWA over the trial period.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRC-AI-SMILES-2018-10210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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