N/A
N=9
Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults
Sleep
Bottom Line
View on ClinicalTrials.gov: NCT03911154 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Psychomotor Vigilance Test-Brief (PVT-B) — 3.59; 4.61; 5.55; 3.95 PVT lapses — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Philips SmartSleep Technology--Continuous Fixed Interval modality (Device); Philips SmartSleep Technology--Block modality (Device); Philips SmartSleep Technology--In-Phase Adjustable modality (Device)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychomotor Vigilance Test-Brief (PVT-B) |
3.59; 4.61; 5.55; 3.95 | 0.36 |
| PRIMARY Slow-wave Activity |
943.13; 1006.00; 972.63; 822.38 | 0.87 |
| SECONDARY Digit Symbol Substitution Test (DSST) |
61.02; 61.73; 58.55; 61.01 | 0.89 |
| SECONDARY Descending Subtraction Task (DST) |
18.52; 19.33; 20.04; 18.84 | 0.76 |
| SECONDARY Robotic On-Board Trainer (ROBoT) Task |
5.61; 5.70; 6.44; 5.73 | 0.64 |
Summary
This study aims to assess whether slow wave sleep enhancement using SmartSleep technology benefits daytime cognitive performance during periods of chronic sleep restriction.
Eligibility Criteria
Inclusion Criteria
- 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 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
- 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.
Data sourced from ClinicalTrials.gov (NCT03911154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.