Trial Outcomes & Findings for Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults (NCT NCT03911154)

Last Updated: 2022-10-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

Days 3-6

Results posted on

2022-10-06

Participant Flow

There are no pre-assignment events to report.

Participant milestones

Participant milestones
Measure	SmartSleep Stimulus Modality This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Please refer to the attached study design and protocol for additional information. Philips SmartSleep Technology: 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: 1. Continuous Fixed Interval: 1 Hz inter-tone interval stimulation 2. Block: 5 seconds on versus 5 seconds off 3. In-Phase Adjustable: constant stimulation with tones to be delivered during each upstate of the slow wave 4. Sham: No auditory stimulation while wearing the SmartSleep headband
Overall Study STARTED	9
Overall Study Continuous Fixed Interval	9
Overall Study Block	9
Overall Study In-Phase Adjustable	9
Overall Study SHAM	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	SmartSleep Stimulus Modality This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Please refer to the attached study design and protocol for additional information. Philips SmartSleep Technology: 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: 1. Continuous Fixed Interval: 1 Hz inter-tone interval stimulation 2. Block: 5 seconds on versus 5 seconds off 3. In-Phase Adjustable: constant stimulation with tones to be delivered during each upstate of the slow wave 4. Sham: No auditory stimulation while wearing the SmartSleep headband
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SmartSleep Modality Assignment n=8 Participants This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband
Age, Continuous	41.9 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
PVT lapses of attention	2.44 PVT lapses STANDARD_DEVIATION 4.98 • n=5 Participants

PRIMARY outcome

Timeframe: Days 3-6

Outcome measures

Outcome measures
Measure	SmartSleep Modality Assignment n=8 Participants This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband
Psychomotor Vigilance Test-Brief (PVT-B) Continuous Fixed Interval	3.59 PVT lapses Standard Deviation 8.18
Psychomotor Vigilance Test-Brief (PVT-B) Block	4.61 PVT lapses Standard Deviation 10.98
Psychomotor Vigilance Test-Brief (PVT-B) In-Phase Adjustable	5.55 PVT lapses Standard Deviation 13.02
Psychomotor Vigilance Test-Brief (PVT-B) Sham	3.95 PVT lapses Standard Deviation 9.11

PRIMARY outcome

Timeframe: Days 3-6

Total delta power measured during sleep

Outcome measures

Outcome measures
Measure	SmartSleep Modality Assignment n=8 Participants This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband
Slow-wave Activity Continuous Fixed Interval	943.13 microvolts^2 Standard Deviation 311.20
Slow-wave Activity Block	1006.00 microvolts^2 Standard Deviation 421.50
Slow-wave Activity In-Phase Adjustable	972.63 microvolts^2 Standard Deviation 485.36
Slow-wave Activity SHAM	822.38 microvolts^2 Standard Deviation 370.59

SECONDARY outcome

Timeframe: Days 3-6

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.

Outcome measures

Outcome measures
Measure	SmartSleep Modality Assignment n=8 Participants This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband
Digit Symbol Substitution Test (DSST) Continuous Fixed Interval	61.02 Correct responses Standard Deviation 11.72
Digit Symbol Substitution Test (DSST) Block	61.73 Correct responses Standard Deviation 11.05
Digit Symbol Substitution Test (DSST) In-Phase Adjustable	58.55 Correct responses Standard Deviation 17.68
Digit Symbol Substitution Test (DSST) Sham	61.01 Correct responses Standard Deviation 12.41

SECONDARY outcome

Timeframe: Days 3-6

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.

Outcome measures

Outcome measures
Measure	SmartSleep Modality Assignment n=8 Participants This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband
Descending Subtraction Task (DST) Continuous Fixed Interval	18.52 Correct responses Standard Deviation 10.18
Descending Subtraction Task (DST) Block	19.33 Correct responses Standard Deviation 9.73
Descending Subtraction Task (DST) In-Phase Adjustable	20.04 Correct responses Standard Deviation 10.97
Descending Subtraction Task (DST) Sham	18.84 Correct responses Standard Deviation 9.41

SECONDARY outcome

Timeframe: Days 3-6

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.

Outcome measures

Outcome measures
Measure	SmartSleep Modality Assignment n=8 Participants This study uses within subject comparison. For each subject, the order of SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 4 stimulation modalities. Philips SmartSleep Technology: 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: 1. Continuous Fixed Interval 2. Block 3. In-Phase Adjustable 4. Sham: No auditory stimulation while wearing the SmartSleep headband
Robotic On-Board Trainer (ROBoT) Task Continuous Fixed Interval	5.61 units on a scale Standard Deviation 2.09
Robotic On-Board Trainer (ROBoT) Task Block	5.70 units on a scale Standard Deviation 1.83
Robotic On-Board Trainer (ROBoT) Task In-Phase Adjustable	6.44 units on a scale Standard Deviation 2.14
Robotic On-Board Trainer (ROBoT) Task Sham	5.73 units on a scale Standard Deviation 2.38

Adverse Events

SmartSleep Continuous Fixed Interval Modality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SmartSleep Block Modality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SmartSleep In-Phase Adjustable Modality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SHAM Condition

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

Dr. David Dinges

University of Pennsylvania

Phone: 215-898-9665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place