Smart Sleep In-home Validation Extension Study

NCT03665844 | Completed

• 1 other identifier: SRC-AI-SMILES-2018-10210
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Healthy; Sleep Deprivation; Insufficient Sleep Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (4)

• Change in performance of the Matrix reasoning task (MRT) correlated to the changes in CSWA over the trial period.

  4 weeks

• Change in performance of the Digital Symbol Substitution Task (DSST) correlated to the changes in CSWA over the trial period.

  4 weeks

• Change in performance of the Psychomotor Vigilance Testing -Brief (PVT) correlated to the changes in CSWA over the trial period.

  4 weeks

• Change in sleepiness/alertness as measured by a 7 point scale correlated to the changes in CSWA over the trial period.

  4 weeks

Study Arms (2)

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.

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.

Device: SmartSleep Boost On

Interventions

SmartSleep Boost On DEVICE

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 On

SmartSleep Boost Off DEVICE

SmartSleep device can be configured to two different settings. SmartSleep Boost Off provides no audio tones.

SmartSleep Boost Off

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

Florida Lung & Sleep Associates

Lehigh Acres, Florida, 33971, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1 week baseline, 3 weeks active condition

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 11, 2018
• Study Start: August 14, 2018
• Primary Completion: November 7, 2018
• Study Completion: November 7, 2018
• Last Updated: November 16, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)