Pilot Study Comparing the Effectiveness of Two Different Methods of Acoustic Stimulation to Enhance Slow Wave Sleep
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Philips Respironics
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participants will wear a PSG both nights, the set-up between devices will not be the same, but similar
Eligibility Criteria
- Ages
- 21 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Parasomnia
- •Circadian Rhythm Sleep-Wake Disorders
- •High Risk of OSA based on STOP-BANG Questionnaire ("yes" on at least 4 of 8 questions)
- •High risk of Restless Legs syndrome (RLS) base on Cambridge-Hopkins Screening Questionnaire
- •High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher)
- •Self-reported history of excessive alcohol intake - self-report > 21 drinks/week or binge alcohol consumption (>5 drinks per day)
- •Individuals who self-report a history of recurrent seizures or epilepsy or family history of hereditary epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
- •Individuals who self-report severe contact dermatitis or allergy to silicone.
- •Individuals who self-report moderate hearing loss.
- •Inability to achieve appropriate headband fit (for prototype 1).
- •Planned air travel or travel across more than one time zone during the anticipated period of the study with PowerSleep or PLL (Northwestern University) device use.
- •Alpha-delta sleep on the first night in the sleep lab.
- •Intentional naps during the work week.
Outcomes
Primary Outcomes
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.
Time Frame: 5 weeks
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.
Secondary Outcomes
- 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)