Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation
Condition: Sleep Deprivation; Insufficient Sleep Syndrome; Healthy
MeSH terms: Sleep Deprivation
Study type: Interventional

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.
    

Detailed description: 
      Each subject will undergo a baseline screening period with screening questionnaires, clinical
      history, and 1 week of actigraphy measurement to determine eligibility for inclusion in the
      study. Prior to the overnight study they will undergo an additional 1 week of actigraphy
      measurement. Each subject will have two 3 day/2 night stays, separated by one week. Including
      outpatient screening and the inpatient study periods, the duration of participation for each
      subject will be ~5 weeks. We anticipate 6 months to enroll and complete the 12 subjects.
      Primary data analysis should be completed within one year of starting this study.

      Study Procedures:

      Participants may be screened over the phone to determine eligibility. A screening script will
      include a general review of key inclusion and exclusion criteria, and the Stop-Bang
      Questionnaire to assess risk for undiagnosed obstructive sleep apnea. Participants that meet
      all eligibility criteria will be asked to come into the research lab for a brief daytime
      screening visit. Participants who are interested and eligible will be consented. Participants
      will be provided with information on use of the actigraph and sleep logs at home.
      Participants will be asked to return their actigraph and sleep logs to the laboratory either
      in person or via pre-paid FedEx. Participant qualification will be assessed based on sleep
      logs and the actigraph results. Qualifying participants will wear the actigraph and fill out
      sleep logs again for the week prior to their first overnight visit.

      Visit 1 (Screening) Procedures (up to 2 hours):

      Participants will be asked to report to the research office for a daytime visit. A detailed
      interview will be performed verifying eligibility criteria, as well as a review of work and
      non-work schedules. After a full explanation of the protocol and after all the participants
      questions have been answered, they will be asked to sign the consent form. Written
      documentation of consent will be obtained for all subjects.

      Participants will complete the following baseline questions:

      Demographics Medical History Questionnaire Collection of Current Medications Epworth
      Sleepiness Scale (ESS) Insomnia Severity Index Questionnaire (ISI) (if not completed during
      telephone screen) Stop-Bang (if not completed during telephone screen) Cambridge Hopkins
      (Restless Leg Syndrome) Questionnaire (if not completed during phone screen)

      Participants will have their height, weight, neck circumference, temperature, heart rate and
      blood pressure recorded. Women of child bearing potential will have a urine pregnancy test.

      Participants will be trained in the use of the sleep logs and actigraphy.

      Actigraphy screening:

      Participants will be asked to wear an actigraph and complete a daily sleep diary for 7 days
      +2 days to monitor their sleep schedule. Participants will receive instructions from the
      study staff on how to wear the actigraph and will be asked to keep to their regular sleep
      schedule.

      Assessment training:

      Participants will also be trained on daytime assessments which will be completed during the
      overnight visits. Only participants that are able to perform the task will be asked to remain
      in the study and through completion.

      Actigraphy review:

      Participants will drop off or mail their actigraph and sleep log to the research office for
      review by the study staff. The actigraph data will be reviewed by a trained technologist.
      Only participants that demonstrate a regular sleep schedule and an average sleep duration of
      6-7 hours during the work week will be asked to return to the lab for the study. A regular
      sleep schedule will be defined as a bedtime between 9pm and midnight with no more than 1 hour
      of variability across the 7 nights. Qualifying participants will be asked to continue wearing
      the actiwatch and completing the sleep diary throughout the remainder of the study.

      Visit 2 Procedures (3 days/2 nights with washout in between nights):

      Participants will be randomly assigned to the sham or active stimulation condition during the
      first night of the overnight visits, and the other condition (sham or active stimulation)
      during the second night of the overnight visits. Participants may also be asked to undergo
      additional night study testing if data collected is unable to be analyzed due to unforeseen
      technical or environmental reasons. Participants and study staff will be blinded to the
      condition they are receiving during each overnight study for prototype 1. However, study
      staff will not be blinded during each overnight for prototype 2.

      Active condition: Participants will be set-up with one of the PowerSleep Prototypes. Soft
      audio tones (below 65dB to prevent arousals from sleep) will be administered via the
      headphones during deep sleep throughout the night.

      Sham condition: Participants will be set up with the same PowerSleep prototype as with the
      active arm, however no audio tones will be played.

      Participants will typically be asked to arrive at the Sleep Lab ~3 hours before their usual
      bedtime.

      Upon arriving at the sleep lab for the first overnight study, the actigraph data will be
      downloaded for review by a trained technologist. Only participants that demonstrate a regular
      sleep schedule and a sleep duration of 6-7 hours per night will be asked to remain in the
      study and through completion.

      The Paired Associated Learning (PAL) learning set will be completed before the participant
      goes to bed.

      Overnight monitoring:

      Participants will complete an attended overnight polysomnogram (PSG). During all PSGs, the
      electroencephalogram (EEG), electrooculogram (EOG) and sub-mental electromyogram (EMG) will
      be recorded with surface electrodes according to American Academy of Sleep Medicine (AASM)
      standards. In addition, surface ECG electrodes (standard lead II) will be applied to the
      participant. All PSG signals will be recorded and monitored continuously by a trained sleep
      technologist throughout the night.

      After the baseline recordings while awake, the PSG channels indicated above will be recorded
      for the participants' entire night of sleep. Participants will be in a private room with the
      door closed and lights off. During the overnight recordings, participants will be directly
      observed via video camera. The participant can contact the trained technologist present at
      any time via an intercom.

      During overnight studies under the active condition, soft auditory tones will be provided via
      the speakers during N3 sleep for prototype 1 and N2 or N3 sleep for prototype 2.

      Morning:

      The participant will be awakened at their usual wake time according to sleep logs and
      actigraphy

      Participants will be asked to complete daytime assessments each morning of the visit (90
      minutes post awakening) including:

      Karolinska Sleepiness Scale (KSS) Samn & Perelli Fatigue Scale Visual Analog Scale (VAS)
      sleep quality Matrix Reasoning Task (MRT) (to be completed on iPad) Digit Symbol Substitution
      Task (DSST) (to be completed on iPad) Psychomotor Vigilance Test (PVT-B - 3min) (to be
      completed on iPad) Paired Associates Learning (PAL)

      The DSST, MRT, PVT-B and PAL assessments will be completed electronically and the other
      assessments will be completed in paper form.

      The actigraph data will be downloaded and the re-configured actigraphy device will be
      returned to the participant to be worn for the period before Visit 4. Sleep logs will be
      given for the participant to fill out during any time at home.

      The subject will be allowed to go home or to work during the day and will be instructed not
      to nap during the day. This will be monitored with the actigraph. The subject will return to
      the lab the following evening 3 hours before the usual bedtime and will be instrumented and
      studied as described for night 1. For example, participants that spent the night Monday and
      completed Tuesday morning testing will come into the lab Wednesday night for Thursday morning
      testing or if participants sent Tuesday night and completed Wednesday morning testing they
      will come into the lab Thursday night for Friday morning testing.

      Visit 4 Procedures (3 days/2 nights):

      Participants will return to the Sleep Disorders Center to complete the second set of
      overnight studies one or two weeks after the first set of overnight studies. If participants
      spent Monday and Wednesday night in the lab for the first set of overnight studies, they will
      complete the second set of overnight visits Monday and Wednesday. The actigraph data will be
      similarly downloaded and reviewed for further participation upon arriving at the Sleep
      Disorders Center. This visit will be identical to Visit 3 except that the subjects will
      receive the prototype system that was not used in Visit 3 (Prototype 1 or 2).
    

Intervention name(s): PowerSleep Stim; Northwestern Stim; PowerSleep Sham; NorthWestern Sham
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 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.; 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.; 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.; 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.
Other intervention name(s): SmartSleep
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, single-blind, sham-controlled pilot cross-over trial comparing
Masking: Single (Participant)
Primary purpose: Treatment