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

Completed · Not applicable · Has a placebo group

Conditions studied: Sleep Deprivation, Insufficient Sleep Syndrome, Healthy

In brief

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.

Key facts

Study ID: NCT03600194
Run by: Philips Respironics
People needed: 38
Starts: 2018-06-01
Expected to finish: 2019-07-25
Last updated by the study team: 2021-06-14

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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
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.

Where it is running

Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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