Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation

NCT03600194 | Completed Results FDA Device

• 1 other identifier: AI-16052-PSCOMP-LO
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, single-blind, sham-controlled pilot cross-over trial comparing the feasibility, and efficacy of 2 nights of in lab use with active versus sham conditions in adults with sleep restricted schedules. The study involves the testing of 2 different prototypes both in the sham and active conditions The expected duration of the study for each participant is up to 5 weeks. It will include adults (21-50 yr. old) who report shortened sleep due to lifestyle. For the purposes of this study, shortened sleep is defined as sleeping at least 5.5 of sleep per night, and sleeping less than or equal to 7 hours of sleep +/- 15 minutes on at least 3/5 work/school nights. Participants also increase their sleep duration by ≥ 1 hour on non-work/school days. In addition, participants report a sleep latency ≤ 30 minutes and wake after sleep onset ≤ 30 minutes. Participants are generally healthy individuals who have not been diagnosed with any sleep-related medical conditions such as obstructive sleep apnea, insomnia, difficulty falling asleep on a nightly basis and deny difficulty staying asleep if awoken during sleep. In addition, participants diagnosed with major organ system diseases or requiring oxygen therapy are excluded from participation. Up to 60 individuals will be consented in order to complete a total of 10 participants using a cross over design. The study involves an initial screening visit followed by 1 week of actigraphy measurement to determine eligibility. Post eligibility, participants will undergo an additional week of actigraphy measurement. Participants will complete 2 overnight visits in the sleep lab per week, with one washout night in between. They will be randomly assigned to sham or active condition during the first of the overnight visits, and the other condition during the second overnight condition. Participants will return to the lab on the same nights the next week and receive the second device in both conditions. Participants will be asked to complete a battery of cognitive tests upon wake up in the lab after each of the overnight visits.

Conditions

Sleep Deprivation; Insufficient Sleep Syndrome; Healthy

Outcome Measures

Primary Outcomes (1)

• The Effects of the Auditory Stimulation on the Cumulative or Average Slow-wave Activity (SWA) Delivered by the PowerSleep & Northwestern Systems in Adults With Mildly Sleep Restricted Schedules as Determined by Device and PSG Scoring Outputs.

  It is hypothesized that one night of in-lab use of a PowerSleep system (Prototype 1) or NorthWestern (Prototype 2) under an active condition (tones played to increase slow-wave activity), as compared to one night of in-lab use of the same PowerSleep system (prototype 1) or Prototype 2 under a sham condition (no tones played) will result in a significant increase (≥ 5%) in cumulative or average slow-wave activity (SWA) in nonREM sleep across the whole night of sleep compared to sham. Note: The relative ability of Prototype 1 versus Prototype 2 to increase the magnitude of SWA in sleep will also be compared.

  5 weeks

Secondary Outcomes (2)

• The Effects of Active and Sham Conditions of PowerSleep and Northwestern University Systems on Psychomotor Vigilance Task - Brief

  5 weeks

• The Effects of Active and Sham Conditions of PowerSleep and Northwestern University Systems on Paired Associated Learning

  5 weeks

Study Arms (4)

PowerSleep Stim

ACTIVE COMPARATOR

In this arm soft audio tones (below 65dB) will be administered by the PowerSleep Stim Device during deep sleep as determined by the functionality of the device.

Device: PowerSleep Stim

PowerSleep Sham

PLACEBO COMPARATOR

This PowerSleep Sham device is the same as the PowerSleep Stim device, however, it can be configured in a mode that does not play audio tones

Device: PowerSleep Sham

Northwestern Stim

ACTIVE COMPARATOR

The NorthWestern Stim device is set up will function similarly to the PowerSleep prototype. Acoustic stimulation provided by headphones with an audible soft volume that do not result in arousals will be used.

Device: Northwestern Stim

Northwestern Sham

PLACEBO COMPARATOR

The Northwestern Sham device will be the same as the Northwestern Stim set up, however no audio tones will be played.

Device: NorthWestern Sham

Interventions

PowerSleep Stim DEVICE

The PowerSleep Stim device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. Soft audio tones (below 65dB) will be administered via the speakers system during deep sleep as determined by the functionality of the device. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.

Also known as: SmartSleep

PowerSleep Stim

Northwestern Stim DEVICE

The Northwestern Stim Device will function similarly to the PowerSleep device, but stimulation will be provided using a standard PC (computer) setup at the bedside using standard PSG electrodes. EEG will be monitored and slow wave sleep (SWS) identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves and to control acoustic stimulation in a phase-locked manner (targeting the up phase of the slow wave). Acoustic stimulation will be provided by headphones with an audible soft volume that do not result in arousals.

Northwestern Stim

PowerSleep Sham DEVICE

The PowerSleep Sham device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. There are no audio tones played in the Sham condition. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.

PowerSleep Sham

NorthWestern Sham DEVICE

The Northwestern Sham device is set up will function similarly to the PowerSleep prototype. EEG will be monitored and SWS identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves. Participant will wear headphones but no audio tones played in the Sham condition.

Northwestern Sham

Eligibility Criteria

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

You may qualify if:

• Able to provide written informed consent prior to admission
• Able to read, write and speak English
• Adult volunteers aged 21-50
• Working full time (M-F) schedule \[Note: Full time is considered a 32 hour work week start time at 7am or later\] or full time student
• Self-reported regular sleep schedule who are able to maintain their sleep schedule during the course of the study
• Self-reported sleep latency ≤ 30 minutes
• Self-reported wake after sleep onset ≤ 30 minutes
• Participants who regularly (3 of 5 work/school nights) use an alarm clock during the work/school week and who self-report:
• Regular sleep schedule of 5.5-7 hours +/- 15 minutes on work/school nights \[confirmed by actigraphy at visit 2, at least 3 of 5 work/school nights between 5.5 to 7 hours total sleep time\]
• Regular increase in sleep duration by ≥ 1 hour during non-work/school days as compared to work days, either by nocturnal bedtime extension or via a daytime nap \[confirmed by actigraphy with at least 1 hour of increased sleep duration during one non-work/school night\]
• Participants who demonstrate successful performance of the Paired Associates Learning Task during the training session

You may not qualify if:

• Participation in another interventional study in the past 30 days.
• Major controlled\* or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, Chronic Obstructive Pulmonary Disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)
• History of current or recent (e.g. within past 5 years) narcotic, or any other drug abuse.
• Daily caffeine intake \> 650mg
• Current smoker (more than 6 cigarettes a week) or those using nicotine replacement therapy. Those that have been nicotine free for 30 days will be included.
• Currently working night shift, split shift or rotating shift (which includes night shifts).
• Current use, or use within the past month, of a prescription or over-the-counter sleep medication or stimulant; or use of psychoactive medication (based on self-report and review with a study clinician) Refer to table below for examples.
• Individuals who self-report a current severe or chronic medical condition that may affect sleep patterns (based on self-report and review with a study clinician).
• Pregnant or currently breast feeding
• Body Mass Index \> 40 kg/m2
• Prior diagnosis (via self report) of any sleep disorder including:
• Obstructive Sleep Apnea (OSA) (AHI ≥15 events/hour) - from ambulatory or in lab polysomnography
• Restless legs syndrome, or periodic limb movement disorder
• Insomnia
• Parasomnia

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, 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

Results Point of Contact

• Title: Jeff Jasko
• Organization: Philips

jeff.jasko@philips.com

412-542-3836

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will wear a PSG both nights, the set-up between devices will not be the same, but similar
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, single-blind, sham-controlled pilot cross-over trial comparing

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 26, 2018
• Study Start: June 1, 2018
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)