SleepNCT03911154
Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults
A study testing Philips SmartSleep Technology--Continuous Fixed Interval modality, Philips SmartSleep Technology--Block modality and Philips SmartSleep Technology--In-Phase Adjustable modality in people with Sleep, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study aims to assess whether slow wave sleep enhancement using SmartSleep technology benefits daytime cognitive performance during periods of chronic sleep restriction. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Philips SmartSleep Technology--Continuous Fixed Interval modality, Philips SmartSleep Technology--Block modality and Philips SmartSleep Technology--In-Phase Adjustable modality
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Bachelor's degree or Master's degree (or the equivalent in work experience) in a relevant field, and/or military service.
- Free of psychological/psychiatric conditions that preclude participation.
- BMI < 35.
- Self-reported regular sleep schedule; able to maintain their sleep schedule during the course of the study.
- Self-reported sleep duration of 6-8.5 hrs per night (verified by 6 work days of ambulatory sleep monitoring with wrist actigraphy and daily logs).
- Ability to read/write English.
Who cannot join
- History of neurological, psychiatric, or other medical condition that excludes participation.
- Current mania or psychosis.
- Current depression as determined by the Beck Depression Inventory (Beck, 1996).
- Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
- Excessive alcohol intake (≥ 21 drinks per week) or binge alcohol consumption (> 5 drinks per day).
- Excessive caffeine consumption (> 650mg/day combining all caffeinated drinks regularly absorbed during the day).
Show all 23Show fewer
- Current smoker/tobacco user, or using nicotine replacement therapy. Those that have been nicotine-free for 30 days will be included.
- Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness based on history, physical exam, blood and urine chemistries, and CBC.
- Individuals who self-report a history of recurrent seizures or epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
- Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that exclude participation.
- Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, COPD, respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report).
- Currently working night, swing, split or rotating shift.
- Current use or use of within the past month of a prescription or over-the-counter sleep medication or stimulant; use of psychoactive medication (based on self-report and review with a study clinician).
- Pregnant or currently breast feeding
- Prior history or diagnosis of any sleep disorder
- High Risk of OSA based on STOP-BANG Questionnaire ("yes" on at least 4 of 8 questions)
- High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire
- High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher)
- Individuals who self-report severe contact dermatitis or allergy to silicone, nickel or silver.
- Individuals who self-report moderate hearing loss.
- Inability to achieve appropriate headband fit.
- Planned travel across more than one time zone one month prior to and/or during the anticipated period of the study with SmartSleeps device use.
- Intentional naps during the week.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults in Order to Mitigate Cognitive Performance Deficits Due to Sleep Restriction and Emergency Awakenings
This study aims to assess whether slow wave sleep enhancement using SmartSleep technology benefits daytime cognitive performance during periods of chronic sleep restriction.
Read the detailed description
Adequate healthy sleep is essential in spaceflight to ensure that astronauts maintain a high level of cognitive performance capability and do so without undue stress. There is a need for a technology that can improve sleep quality in space and biologically maximize the performance benefits of limited sleep duration, without unduly affecting the ability of astronauts to awaken abruptly and respond to an in-flight emergency. Sleep slow waves support system and synaptic consolidation by promoting specific patterns of neuromodulatory and electric activities, and subjective sleep quality is related to the size and number of slow waves that occur nightly.
This study will use SmartSleep (Philips) technology to determine what effect the device has on daytime cognitive performance after emergent awakenings from sleep in a chronic sleep restriction paradigm. The SmartSleep technology uses two small sensors in the headband to continuously detect the brain's slow wave sleep (delta/theta frequency) in real time, and a closed-loop algorithm customizes the timing and volume of tones to optimize the sleep pattern. Thus, the device uses "quiet audio tones" (sub-awareness) to increase slow waves, which can enhance sleep quality/depth, thereby enhancing subsequent waking cognitive performance without the unwanted sedating effects of medications on cognitive functions during emergency awakenings.
Subjects will be in the laboratory for 7 days/6 nights. Night 1 will be an adaptation night with 8-hours time in bed. Nights 2-5 will consist of 5 hours time in bed, followed by night 6 of a recovery 10 hours time in bed. During nights 2-5, subjects will receive one of four stimulation modalities using the SmartSleep wearable device. Subjects will receive all four modalities in a randomized order:
- Continuous Fixed Interval
- Block
- In-Phase Adjustable
- Sham: No auditory stimulation while wearing the SmartSleep headband
Cognitive performance testing and self-report surveys will be completed on a daily basis. A total of 12 healthy astronaut-like adults will be studied. Subjects will complete the 7-day study in groups of 4.
- Conditions
- Sleep
- Being tested
- Philips SmartSleep Technology--Continuous Fixed Interval modality, Philips SmartSleep Technology--Block modality, Philips SmartSleep Technology--In-Phase Adjustable modality
- Keywords
- Sleep, Sleep restriction, Cognitive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips SmartSleep Technology--Continuous Fixed Interval modalityDevice
During the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities:
- Continuous Fixed Interval
- Block
- In-Phase Adjustable
- Sham: No auditory stimulation while wearing the SmartSleep headband
Philips SmartSleep Technology--Block modalityDevice
During the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities:
- Continuous Fixed Interval
- Block
- In-Phase Adjustable
- Sham: No auditory stimulation while wearing the SmartSleep headband
Philips SmartSleep Technology--In-Phase Adjustable modalityDevice
During the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities:
- Continuous Fixed Interval
- Block
- In-Phase Adjustable
- Sham: No auditory stimulation while wearing the SmartSleep headband
| Study group | Role | What they receive |
|---|---|---|
| SmartSleep Continuous Fixed Interval modality | Experimental | This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep Continuous Fixed Interval stimulation modality during sleep relative to the SHAM condition. The Continuous Fixed Interval is the delivery of auditory tones a 1 Hz inter-tone interval stimulation. Receives: Device: Philips SmartSleep Technology--Continuous Fixed Interval modality; Device: Philips SmartSleep Technology--Block modality; Device: Philips SmartSleep Technology--In-Phase Adjustable modality |
| SmartSleep Block modality | Experimental | This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep Block stimulation modality during sleep relative to the SHAM condition. The Block is the delivery of auditory tones for 5 seconds on versus 5 seconds off. Receives: Device: Philips SmartSleep Technology--Continuous Fixed Interval modality; Device: Philips SmartSleep Technology--Block modality; Device: Philips SmartSleep Technology--In-Phase Adjustable modality |
| SmartSleep In-Phase Adjustable modality | Experimental | This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep In-Phase Adjustable stimulation modality during sleep relative to the SHAM condition. The In-Phase Adjustable is the constant stimulation with auditory tones delivered during each upstate of the slow wave. Receives: Device: Philips SmartSleep Technology--Continuous Fixed Interval modality; Device: Philips SmartSleep Technology--Block modality; Device: Philips SmartSleep Technology--In-Phase Adjustable modality |
| SHAM condition | Sham comparator | This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm is the SHAM condition, during which participants wore the SmartSleep device, however no auditory tones were delivered. Receives: Device: Philips SmartSleep Technology--Continuous Fixed Interval modality; Device: Philips SmartSleep Technology--Block modality; Device: Philips SmartSleep Technology--In-Phase Adjustable modality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Test-Brief (PVT-B)
The PVT is a simple reaction time test that requires participants to react, as quickly as possible, by pressing a response key as soon as a rolling number counter presented in a box in the center of the computer screen appears. The PVT is a validated and widely-used measure of vigilant attention that is sensitive to the effects of sleep loss. The primary outcome was the number of PVT lapses. The minimum number of PVT lapses is "0" and there is no maximum number of lapses, which are defined as response times >355 ms. More PVT lapses indicates worse performance.
Measured: Days 3-6
Slow-wave Activity
Total delta power measured during sleep
Measured: Days 3-6
Secondary outcomes (3)
Digit Symbol Substitution Test (DSST)
The Digit Symbol Substitution Test (DSST) is a widely used measure of cognitive throughput and cognitive instability that is sensitive to the effects of sleep loss. The DSST was adapted from the Wechsler Adult Intelligence Scale. Participants are shown an array of symbols and with corresponding numbers on a keyboard. They are then presented the symbols one at a time in random order and must respond with the correct corresponding number as quickly as possible. The primary outcome was number correct and given the established practice effects on the DSST, this measure was corrected for practice effects. The DSST has a minimum of "0" correct responses and does not have a maximum; a higher number on the DSST represents better performance.
Measured: Days 3-6
Descending Subtraction Task (DST)
The Descending Subtraction Test (DST) is a measure of working memory that is sensitive to the effects of sleep loss. The DST requires participants to mentally subtract numbers in a sequential fashion as quickly as possible. For example, if the starting number is 987, the participant subtracts nine from 987, with the difference being 978, the participant then subtracts eight from 978, and so on subtracting by seven, six, five, four, three, two, and one, from each difference at which point, and the participant then recycles the subtraction sequence beginning at nine again. The DST has a minimum of "0" correct responses and does not have a maximum; a higher number on the DST represents better performance. The primary outcome on the DST was Number correct.
Measured: Days 3-6
Robotic On-Board Trainer (ROBoT) Task
The Robotic On-Board Trainer (ROBoT) task is NASA's platform for training astronauts to perform docking and grappling maneuvers using the Canada Arm. The system is based on highly realistic 3D simulations of the arm and associated physics. The ROBoT system involves a left-hand translational controller (x/y/z directions) and a right-hand rotational controller (pitch/roll/yaw), plus two laptop computer screens. Key performance metrics include: (i) docking position accuracy, (ii) docking orientation accuracy, (iii) total task time, and (iv) smoothness of approach trajectory, which are aggregated to generate the primary outcome, which is the mean weighted score . The weighted score ranges from 0 to 10 and a lower score indicates better performance.
Measured: Days 3-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start29 Apr 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses within subject randomization. Each subject will receive all of the 4 sleep conditions in a randomized order that will be unknown to the subject.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA), Philips Healthcare, University of Wisconsin, Madison
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911154
- Sponsor's protocol ID
- NNX16AO69A/T0408
- Status last verified
- Sep 2022
- First submitted
- 4 Apr 2019
- Last updated
- 6 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults in Order to Mitigate Cognitive Performance Deficits Due to Sleep Restriction and Emergency Awakenings
- ClinicalTrials.gov ID
- NCT03911154
- Acronym / sponsor ID
- NNX16AO69A/T0408
- Conditions
- Sleep
- Keywords
- Sleep, Sleep restriction, Cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA), Philips Healthcare, University of Wisconsin, Madison
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess whether slow wave sleep enhancement using SmartSleep technology benefits daytime cognitive performance during periods of chronic sleep restriction.
Detailed description
Adequate healthy sleep is essential in spaceflight to ensure that astronauts maintain a high level of cognitive performance capability and do so without undue stress. There is a need for a technology that can improve sleep quality in space and biologically maximize the performance benefits of limited sleep duration, without unduly affecting the ability of astronauts to awaken abruptly and respond to an in-flight emergency. Sleep slow waves support system and synaptic consolidation by promoting specific patterns of neuromodulatory and electric activities, and subjective sleep quality is related to the size and number of slow waves that occur nightly.
This study will use SmartSleep (Philips) technology to determine what effect the device has on daytime cognitive performance after emergent awakenings from sleep in a chronic sleep restriction paradigm. The SmartSleep technology uses two small sensors in the headband to continuously detect the brain's slow wave sleep (delta/theta frequency) in real time, and a closed-loop algorithm customizes the timing and volume of tones to optimize the sleep pattern. Thus, the device uses "quiet audio tones" (sub-awareness) to increase slow waves, which can enhance sleep quality/depth, thereby enhancing subsequent waking cognitive performance without the unwanted sedating effects of medications on cognitive functions during emergency awakenings.
Subjects will be in the laboratory for 7 days/6 nights. Night 1 will be an adaptation night with 8-hours time in bed. Nights 2-5 will consist of 5 hours time in bed, followed by night 6 of a recovery 10 hours time in bed. During nights 2-5, subjects will receive one of four stimulation modalities using the SmartSleep wearable device. Subjects will receive all four modalities in a randomized order:
- Continuous Fixed Interval
- Block
- In-Phase Adjustable
- Sham: No auditory stimulation while wearing the SmartSleep headband
Cognitive performance testing and self-report surveys will be completed on a daily basis. A total of 12 healthy astronaut-like adults will be studied. Subjects will complete the 7-day study in groups of 4.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This study uses within subject randomization. Each subject will receive all of the 4 sleep conditions in a randomized order that will be unknown to the subject.
| Arm | Type | Receives |
|---|---|---|
| SmartSleep Continuous Fixed Interval modality | Experimental | Device: Philips SmartSleep Technology--Continuous Fixed Interval modality, Device: Philips SmartSleep Technology--Block modality, Device: Philips SmartSleep Technology--In-Phase Adjustable modalityThis study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition. This study arm tests the SmartSleep Continuous Fixed Interval stimulation modality during sleep relative to the SHAM condition. The Continuous Fixed Interval is the delivery of auditory tones a 1 Hz inter-tone interval stimulation. |
| SmartSleep Block modality | Experimental | Device: Philips SmartSleep Technology--Continuous Fixed Interval modality, Device: Philips SmartSleep Technology--Block modality, Device: Philips SmartSleep Technology--In-Phase Adjustable modalityThis study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition. This study arm tests the SmartSleep Block stimulation modality during sleep relative to the SHAM condition. The Block is the delivery of auditory tones for 5 seconds on versus 5 seconds off. |
| SmartSleep In-Phase Adjustable modality | Experimental | Device: Philips SmartSleep Technology--Continuous Fixed Interval modality, Device: Philips SmartSleep Technology--Block modality, Device: Philips SmartSleep Technology--In-Phase Adjustable modalityThis study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition. This study arm tests the SmartSleep In-Phase Adjustable stimulation modality during sleep relative to the SHAM condition. The In-Phase Adjustable is the constant stimulation with auditory tones delivered during each upstate of the slow wave. |
| SHAM condition | Sham comparator | Device: Philips SmartSleep Technology--Continuous Fixed Interval modality, Device: Philips SmartSleep Technology--Block modality, Device: Philips SmartSleep Technology--In-Phase Adjustable modalityThis study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition. This study arm is the SHAM condition, during which participants wore the SmartSleep device, however no auditory tones were delivered. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Bachelor's degree or Master's degree (or the equivalent in work experience) in a relevant field, and/or military service.
- Free of psychological/psychiatric conditions that preclude participation.
- BMI < 35.
- Self-reported regular sleep schedule; able to maintain their sleep schedule during the course of the study.
- Self-reported sleep duration of 6-8.5 hrs per night (verified by 6 work days of ambulatory sleep monitoring with wrist actigraphy and daily logs).
Key exclusion criteria (23 listed)
- History of neurological, psychiatric, or other medical condition that excludes participation.
- Current mania or psychosis.
- Current depression as determined by the Beck Depression Inventory (Beck, 1996).
- Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
- Excessive alcohol intake (≥ 21 drinks per week) or binge alcohol consumption (> 5 drinks per day).
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 |
|---|---|---|
| Philips SmartSleep Technology--Continuous Fixed Interval modalityDuring the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband | Device | SHAM condition, SmartSleep Block modality, SmartSleep Continuous Fixed Interval modality, SmartSleep In-Phase Adjustable modality |
| Philips SmartSleep Technology--Block modalityDuring the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband | Device | SHAM condition, SmartSleep Block modality, SmartSleep Continuous Fixed Interval modality, SmartSleep In-Phase Adjustable modality |
| Philips SmartSleep Technology--In-Phase Adjustable modalityDuring the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband | Device | SHAM condition, SmartSleep Block modality, SmartSleep Continuous Fixed Interval modality, SmartSleep In-Phase Adjustable modality |
Primary outcome
Psychomotor Vigilance Test-Brief (PVT-B)
Time frame: Days 3-6
The PVT is a simple reaction time test that requires participants to react, as quickly as possible, by pressing a response key as soon as a rolling number counter presented in a box in the center of the computer screen appears. The PVT is a validated and widely-used measure of vigilant attention that is sensitive to the effects of sleep loss. The primary outcome was the number of PVT lapses. The minimum number of PVT lapses is "0" and there is no maximum number of lapses, which are defined as response times >355 ms. More PVT lapses indicates worse performance.
Slow-wave Activity
Time frame: Days 3-6
Total delta power measured during sleep
3 secondary outcomes
Digit Symbol Substitution Test (DSST)
Time frame: Days 3-6
Descending Subtraction Task (DST)
Time frame: Days 3-6
Robotic On-Board Trainer (ROBoT) Task
Time frame: Days 3-6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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 Philips SmartSleep Technology--Continuous Fixed Interval modality, Philips SmartSleep Technology--Block modality and Philips SmartSleep Technology--In-Phase Adjustable modality in people with Sleep, run by University of Pennsylvania 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 6 inclusion and 23 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 6 Oct 2022. 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?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Psychomotor Vigilance Test-Brief (PVT-B) (time frame: Days 3-6). The study lists 2 primary outcomes in all. 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 6 Oct 2022.