Please enable javascript. Patented Pain Relief Technology & Sleep Research - 10 Years of Development, Clinical Trials: Level Sleep®

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10 Years of Development, Clinical Trials, and Issuance of Multiple Patents

Proven Reduction of Pain

The inventors of Level Sleep’s patented design have been active in sleep and sleep research for more than 15 years. Level Sleep® began dedicated sleep research through the development of the Level Restore™ pillow, which was clinically tested by Dr. Clete Kushida, medical director of the Sleep Medicine Center, and director of the Center for Human Sleep Research. Encouraged by Stanford researchers, Level Sleep® went on to develop the patented TriSupport® mattress which is now recommended by Doctors and Chiropractors.

Level Sleep® features three zones to support the curves and weights of the body. Each zone features a unique sleep surface, including a lumbar zone that supports both back and side sleepers. Level Sleep® rigorously tested the mattress for its effectiveness in reducing pain, improving sleep and daytime function versus other traditional designs.

Level Sleep® with TriSupport® is the only mattress I’ve found that reduces the build up of pressure that leads to tossing and turning, which causes sleep fragmentation. That’s why I sleep on one.

Dr. Nick Athens

Chiropractic Advisor, Team Chiropractor, San Francisco 49ers Football Team

Results

Better Sleep

The subjects of the study rated the quality of their sleep as significantly better while sleeping on the Level Sleep® mattress compared to their current mattresses on three different subjective sleep assessment tools (Pittsburgh Sleep Quality Index, sleep journals, and morning questionnaire).

Reduced Morning Pain And Stiffness

Level’s lumbar support enables an even distribution of pressure across the pelvic, lumbar and thoracic areas, while limiting compressive forces on the spine so you can wake up refreshed. The subjects reported significantly less pain and stiffness in the morning.

Mattress Study Results*

Sleep Quality
Pain Reduction
Daytime Function
55.5% reduction (PSQI) Sleep latency (Time required to fall asleep p-value: 0.001)
57.1% reduction (Morning Rating Scales) Pain reduction (p-value: 0.001)
62.5% reduction (PSQI) Day dysfunction due to sleepiness (p-value: <0.001
34.5 % reduction (Morning Rating Scales) Tossing and turning (p-value: <0.001)
53.7% reduction (Morning Rating Scales) Stiffness (p-value: <0.001)
43.2% reduction (Morning Rating Scales) Fatigue (p-value: <0.001)
17.2% reduction (Braebon Medibyte) Total body position p-value: 0.005)
60.4 % increase (Morning Rating Scales) Sleep Satisfaction (p-value: <0.001)
30.0 % reduction (Morning Rating Scales) Awakenings (p-value: 0.003)
24.5% increase (Sleep Journals) Quality of sleep rating (p-value: <0.001)

*Mattress study conducted with same patented design as current Level Sleep® mattress, but under a different brand name

Reduced Tossing And Turning

The subjects reported less tossing and turning throughout the night while sleeping on the Level Sleep® Mattress vs. their current mattress. Level’s patented design allows for a more even distribution of pressure, which reduces tossing and turning and improves sleep while reducing morning pain and stiffness.

Fell Asleep Faster And Reduced Next-Day Fatigue

The subjects also reported less time spent awake after sleep onset and less daytime sleepiness after sleeping on the Level Sleep® mattress vs. their current mattresses. Compared to their reports at baseline and on their current mattresses, subjects also indicated that they were able to fall asleep quicker and had less disturbed sleep on the Level Sleep® mattress. Objective measures of body position transitions revealed that there were less transitions while subjects slept on the LevelSleep mattress compared to their current mattresses.

Figure 2.0 : Pressure Map
Figure 3.0 : Pound Per Square Inch Pressure

Our bodies need at least seven hours per night to rejuvenate. And no one knows that better that the people behind Level Sleep®, who are focused on designing products that enhance restful sleep so that you can perform your best on the job, at the gym, on the field — anywhere.

Dr. Athens

Methodology

In 2009, Level Sleep® commissioned a 30-person, Institutional Review Board (IRB) approved, single-blind sleep trial, again designed by Clete Kushida, M.D., PhD., in which study participants tested their current mattress against ours. The study was conducted by Cheri Mah, MS, Sleep Researcher.

Dr. Kushida’s research demonstrated that TriSupport® allowed participants to fall asleep more quickly, wake up with less pain and stiffness, and report significantly more energy and sleep satisfaction

Objective data was collected via Braebon Medibyte and Actiwatch sensor devices. Subjective data was collected through a series of established questionnaires including Morning Rating Scales, the Pittsburgh Sleep Quality Index (PSQI), and the Epworth Sleepiness Scale (ESS).

Full statistical analysis was done to ascertain statistical significance.

Clinical Trial Subjects

CATEGORY CONDITION 1 CONDITION 2 CONDITION 3
Gender Male (16) Female (14)
Age 18-30 (8) 30-45 (12) Over 45 (10)
Bed Partner Yes (14) No (16)
Figure 1.0
CATEGORY Gender
CONDITION 1 Female (14)
CONDITION 2 Male (16)


CATEGORY Age
CONDITION 1 18-30 (8)
CONDITION 2 30-45 (12)
CONDITION 3 Over 45 (10)


CATEGORY Bed Partner
CONDITION 1 Yes (14)
CONDITION 2 No (16)
Figure 1.0

56%+ reduction of pain*

By promoting spinal alignment and pressure reduction, Level Sleep’s patented TriSupport® design helped reduce pain for trial participants by over 56% according to Morning Rating Scales. TriSupport lumbar support enables a more even distribution of pressure across the pelvic, lumbar and thoracic areas, while limiting compressive and shearing forces on the spine.

Figure 1.0 : Spinal Alignment

There’s an even distribution [with Level] throughout the entire spine to get a good restful sleep. And this is a breathable material so you’re not going to get hot, you’re going to get more oxygen into your cells and your tissues so you get a much better healthier night’s sleep.

Dr. Tim Smith

New Life Chiropractic

How We Fight Pain

Fighting Back Pain

Regardless of sleeping position, your weight is absorbed primarily by your hips and shoulder blades, leaving your lower spine—the lumbar region—unsupported. This causes your spine to sag just above the pelvis, stressing the soft tissues in your lumbar region and resulting in pain or discomfort. A study published in the Journal of the Canadian Chiropractic Association showed that lumbar support enables a more even distribution of pressure across the pelvic, lumbar and thoracic areas, while limiting compressive and shearing forces on the spine. That is why participants in our clinical trial reported a 54% reduction in morning stiffness.

Fighting Shoulder Pain

Compression of the soft tissues between the bone structure of your shoulders and the mattress surface restricts blood flow and causes tingling, numbness, and pain. Your body naturally responds to this discomfort by tossing and turning. The Level Sleep® TriSupport® mattress features a soft shoulder zone that absorbs the weight of your shoulders while the complementary lumbar and hip zones keep your body aligned. That is why participants in our clinical trial reported a 56% reduction in morning pain and a 34% reduction in tossing and turning.

Fighting Tossing and Turning

Compression of the soft tissues between the bone structure of your hips and shoulders and the mattress surface restricts blood flow. The result is a burning sensation, which is a major cause of tossing and turning. TriSupport®’s three zones work together to prevent pressure build up. Less pressure and pain directly translates to less tossing and turning and better sleep. This is why our clinical trial participants experienced 34% less tossing and turning and woke up with 43% less fatigue and 63% less daytime dysfunction due to sleepiness.

Patented Design Promotes Spinal Alignment While You Sleep

Level’s patented three zone design works together to prevent pressure buildup. Less pressure and reduced pain directly translates to less tossing and turning and better sleep.

Level Restore™ Pillow

A team of researchers at Stanford University found that use of a pillow with Level Sleep’s unique design resulted in a 78% reduction in the number of snoring events and a 86% reduction in the duration of snoring events.

In a series of clinical trials conducted with a total of 29 subjects with obstructive sleep apnea and published in three separate journal articles, a team of researchers at Stanford University Sleep Disorders Clinic and Research Center, led by Dr. Clete Kushida, found that use of a special pillow, now part of Level Sleep’s portfolio of sleep products, significantly reduced the frequency of sleep-disordered breathing.

Specifically, in an article published in Sleep Research Online titled ”Cervical Positional Effects on Snoring and Apneas,” Kushida , Dement, et al. found the design behind Level Sleep’s Restore™ Pillow resulted in a:

  • — 78% reduction in the number of snoring events
  • — 86% reduction in duration of snoring events
  • — 24% reduction in obstructive sleep apnea

The since updated and improved version of the Level Sleep® Restore™ Pillow went on to gain FDA 510(k) clearance, having been clinically tested and shown to be helpful in reducing snoring.

How and Why It Works

Level Sleep® products fight pain and improve sleep quality because they are designed for the human form™. Too much or too little support puts pressure on your soft tissues, neck muscles, and your cervical spine. As a result, you are likely to suffer from both shoulder pain and neck pain when sleeping on a sub-optimal pillow. Level Sleep® has designed height-adjustable Restore™ pillows with holes or ear wells in the pillow surfaces that allow side-sleepers ears to float pressure-free. The pillow also features an Ergonomic Comfort Center that allows your head to tilt back, naturally maintaining the curve of the cervical spine, while also opening up your airways to reduce snoring.

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