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

NCT03911154 | Completed Results FDA Device

• 1 other identifier: NNX16AO69A/T0408
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess whether slow wave sleep enhancement using SmartSleep technology benefits daytime cognitive performance during periods of chronic sleep restriction.

Conditions

Sleep

Keywords

Sleep; Sleep restriction; Cognitive performance

Outcome Measures

Primary Outcomes (2)

• 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.

  Days 3-6

• Slow-wave Activity

  Total delta power measured during sleep

  Days 3-6

Secondary Outcomes (3)

• Digit Symbol Substitution Test (DSST)

  Days 3-6

• Descending Subtraction Task (DST)

  Days 3-6

• Robotic On-Board Trainer (ROBoT) Task

  Days 3-6

Study Arms (4)

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.

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.

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.

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.

Device: Philips SmartSleep Technology--Continuous Fixed Interval modality; Device: Philips SmartSleep Technology--Block modality; Device: Philips SmartSleep Technology--In-Phase Adjustable modality

Interventions

Philips SmartSleep Technology--Continuous Fixed Interval modality DEVICE

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

SHAM condition; SmartSleep Block modality; SmartSleep Continuous Fixed Interval modality; SmartSleep In-Phase Adjustable modality

Philips SmartSleep Technology--Block modality DEVICE

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

SHAM condition; SmartSleep Block modality; SmartSleep Continuous Fixed Interval modality; SmartSleep In-Phase Adjustable modality

Philips SmartSleep Technology--In-Phase Adjustable modality DEVICE

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

SHAM condition; SmartSleep Block modality; SmartSleep Continuous Fixed Interval modality; SmartSleep In-Phase Adjustable modality

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Aeronautics and Space Administration (NASA): collaborator
• Philips Healthcare: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Limitations and Caveats

The primary limitation of this study is the small sample size and given the small sample, caution in interpreting the results is warranted.

Results Point of Contact

• Title: Dr. David Dinges
• Organization: University of Pennsylvania

dinges@pennmedicine.upenn.edu

215-898-9665

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The SmartSleep device will be programmed by investigators not involved in study execution. Subjects will wear the SmartSleep device each night and will be unaware of the order of stimulation modalities. In addition, both study personnel and those assessing outcomes will not be aware of the order of stimulation modalities.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 10, 2019
• Study Start: April 29, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 6, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)