HealthyNCT03665844
Smart Sleep In-home Validation Extension Study
A study testing SmartSleep Boost On and SmartSleep Boost Off in people with Healthy and Sleep Deprivation, run by Philips Respironics at 1 site in United States.
Trial summary
This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting. It is intended to provide data related to product use and cognitive testing incorporating a longer baseline period for comparison purposes. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Healthy, Sleep Deprivation, Insufficient Sleep Syndrome
- What is being tested?
- SmartSleep Boost On and SmartSleep Boost Off
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2018to 7 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Lung & Sleep Associates
Lehigh Acres, Florida, 33971
About this study
This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting. It is intended to provide data related to product use and cognitive testing incorporating a longer baseline period for comparison purposes. It will include adults (21-50 yr. old) who are working full time and report shortened sleep due to lifestyle. For the purposes of this study, shortened sleep is defined as sleeping at least 5 hrs. of sleep per night, and sleeping less than or equal to 7 hrs. at least 3 nights per week. Participants also increase their sleep duration by ≥ 1 hour on the weekends. In addition, participants report a sleep latency ≤ 30 minutes less than or equal to 3 nights per week. Participants are generally healthy individuals who have not been diagnosed with any sleep-related medical conditions. In addition, participants diagnosed with major organ system diseases or requiring oxygen therapy are excluded from participation. Up to 75 individuals will be consented in order to complete a total of 50 participants using a nonrandomized design. The study involves an initial screening visit followed by home use of the SmartSleep device with SleepMapper app. The home use will include an initial week of baseline use followed by 3 weeks of use with boost on. Study staff will contact participants after the first week of use as a reminder. Participants will be asked to complete a battery of cognitive tests upon wake up each morning. Participants will be asked to complete a question twice daily during the home use period. Additional phone calls may occur on an as needed basis if issues arise. The final visit will be an in facility visit in which all study equipment will be returned. The anticipated study duration will be up to 6 weeks (including the 4 weeks of use period).
Read the 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.
- Conditions
- Healthy, Sleep Deprivation, Insufficient Sleep Syndrome
- Being tested
- SmartSleep Boost On, SmartSleep Boost Off
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartSleep Boost OnDevice
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).
SmartSleep Boost OffDevice
SmartSleep device can be configured to two different settings. SmartSleep Boost Off provides no audio tones.
| Study group | Role | What they receive |
|---|---|---|
| SmartSleep Boost Off | Placebo comparator | Participants wear the device for baseline data collection in boost off mode. There is no intervention. This is known as SmartSleep Boost Off mode. Receives: Device: SmartSleep Boost Off |
| SmartSleep Boost On | Active comparator | Participants wear the device for 3 weeks in boost on mode. This is known as SmartSleep Boost On mode. Receives: Device: SmartSleep Boost On |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 4 weeks
Secondary outcomes (4)
Change in performance of the Matrix reasoning task (MRT) correlated to the changes in CSWA over the trial period.
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.
Measured: 4 weeks
Change in performance of the Digital Symbol Substitution Task (DSST) correlated to the changes in CSWA over the trial period.
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.
Measured: 4 weeks
Change in performance of the Psychomotor Vigilance Testing -Brief (PVT) correlated to the changes in CSWA over the trial period.
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.
Measured: 4 weeks
Change in sleepiness/alertness as measured by a 7 point scale correlated to the changes in CSWA over the trial period.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start14 Aug 2018
- Primary completion7 Nov 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 1 week baseline, 3 weeks active condition
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665844
- Sponsor's protocol ID
- SRC-AI-SMILES-2018-10210
- Status last verified
- Nov 2018
- First submitted
- 5 Sep 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. This data will remain with Florida Lung \& Sleep Associates and Philips
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Sleep In-home Validation Extension Study
- ClinicalTrials.gov ID
- NCT03665844
- Acronym / sponsor ID
- SRC-AI-SMILES-2018-10210
- Conditions
- Healthy, Sleep Deprivation, Insufficient Sleep Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 7 Nov 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting. It is intended to provide data related to product use and cognitive testing incorporating a longer baseline period for comparison purposes. It will include adults (21-50 yr. old) who are working full time and report shortened sleep due to lifestyle. For the purposes of this study, shortened sleep is defined as sleeping at least 5 hrs. of sleep per night, and sleeping less than or equal to 7 hrs. at least 3 nights per week. Participants also increase their sleep duration by ≥ 1 hour on the weekends. In addition, participants report a sleep latency ≤ 30 minutes less than or equal to 3 nights per week. Participants are generally healthy individuals who have not been diagnosed with any sleep-related medical conditions. In addition, participants diagnosed with major organ system diseases or requiring oxygen therapy are excluded from participation. Up to 75 individuals will be consented in order to complete a total of 50 participants using a nonrandomized design. The study involves an initial screening visit followed by home use of the SmartSleep device with SleepMapper app. The home use will include an initial week of baseline use followed by 3 weeks of use with boost on. Study staff will contact participants after the first week of use as a reminder. Participants will be asked to complete a battery of cognitive tests upon wake up each morning. Participants will be asked to complete a question twice daily during the home use period. Additional phone calls may occur on an as needed basis if issues arise. The final visit will be an in facility visit in which all study equipment will be returned. The anticipated study duration will be up to 6 weeks (including the 4 weeks of use period).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1 week baseline, 3 weeks active condition
| Arm | Type | Receives |
|---|---|---|
| SmartSleep Boost Off | Placebo comparator | Device: SmartSleep Boost OffParticipants wear the device for baseline data collection in boost off mode. There is no intervention. This is known as SmartSleep Boost Off mode. |
| SmartSleep Boost On | Active comparator | Device: SmartSleep Boost OnParticipants wear the device for 3 weeks in boost on mode. This is known as SmartSleep Boost On mode. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (19 listed)
- Individuals who self-report severe contact dermatitis or an allergy to silver
- Diagnosed as having any of the following conditions (via self-report):
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartSleep Boost OnSmartSleep 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). | Device | SmartSleep Boost On |
| SmartSleep Boost OffSmartSleep device can be configured to two different settings. SmartSleep Boost Off provides no audio tones. | Device | SmartSleep Boost Off |
Primary outcome
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 secondary outcomes
Change in performance of the Matrix reasoning task (MRT) correlated to the changes in CSWA over the trial period.
Time frame: 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
Change in performance of the Psychomotor Vigilance Testing -Brief (PVT) 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 correlated to the changes in CSWA over the trial period.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Individual participant dataSharing planned: No. No. This data will remain with Florida Lung \& Sleep Associates and Philips
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartSleep Boost On and SmartSleep Boost Off in people with Healthy and Sleep Deprivation, run by Philips Respironics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.