Read about the results of Lullabee's research study led by a team from Duke University's renowned Sleep Disorders Clinic.
--
Do you nerd out on science like we do? If so, this article is for you!
Lullabee was invented by a Duke Pediatric Neurologist and Sleep Medicine physician, Dr. Sujay Kansagra. As a dual-boarded physician in both neurology and pediatrics, he’s spent his career treating patients for sleep disorders, researching sleep, and writing scientific papers and books. It only made sense that someone so dedicated to sleep science would want to scientifically demonstrate his invention’s positive impact on sleep before introducing it to the market.
With the help of a dedicated team of Duke engineers, Dr. Kansagra designed the first Lullabee prototype just a couple of years ago. This prototype functioned well, but was far from what Lullabee is today.
Time Capsule: The First Lullabee Prototype!
How was the study designed? The research team started by asking biostatisticians how many infants they would need to enroll to ensure they could prove whether the device worked or not, known as an a priori power analysis.
Following this, they received approval to perform the study through the Duke Institutional Review Board (IRB) and registered it with the National Institutes of Health. Once all the approvals were in place, Dr. Kansagra reached out to Duke pediatricians to help recruit 19 infants between the ages of 2 and 11 months to participate in the study.
Each participant went through a 30-day trial. The 30 days were broken down as follows:
Days 1-5:
The infant slept on the Lullabee mattress, but the mattress did nothing except track sleep patterns. There was no vibration or audio from the mattress. Families filled out daily sleep diaries regarding what times the infant slept, how often they woke up, how many naps they took, and how much help they needed to fall asleep. Parents also filled out three validated questionnaires on day five that asked about the infants' sleep behavior, parental perception of infant sleep, parental sleepiness, and parental mood over the last five days. The scales are known as BISQ-SF, the Epworth Sleepiness Scale (ESS), and the PHQ-2.
Why did the mattress do nothing for the first five days? The researchers wanted to ensure that each infant's baseline data was collected while sleeping on this new mattress. It is possible that simply sleeping on a new mattress could have changed infant sleep. Perhaps, for example, it was more comfortable than their old mattress. For this reason, it was essential to gather baseline data while actually using the Lullabee mattress.
Days 6 through 15:
During the next ten days, the Lullabee mattress entered phase 1. In phase 1, the mattress provided vibration and sound all the way up to level 10 if the child was awake and crying. It did this repeatedly throughout the entire night and during naps. The goal was to get the infant accustomed to using the mattress to help them fall asleep.
Days 16 through 25:
During the next ten days, Lullabee was programmed to start automatically weaning the level of output it gave the child each night. Regardless of how well the child slept, it began slowly weaning the output. By day 25, Lullabee had weaned its output down to level 1.
Days 26-30:
Once again, the mattress produced no output during these five days. There was no vibration or sound. This allowed the study team to collect post-intervention data for five days. They wanted to know if the child was now sleeping differently even when Lullabee was no longer working. Similar to the first five days of use, parents filled out sleep diaries for every single night and then filled out the same three surveys on day 30 (BISQ-SF, ESS, and PHQ-2)
Results
On nights 1 through 5 of the study, infants woke up an average of 12.9 times. At the end of the study, on nights 26-30, infants woke up an average of 8.5 times. This was a statistically significant decrease in awakenings.
In addition, scores from the BISQ-SF survey showed a vast improvement. Total scores improved, as did scores in all three subcategories, including the infant sleep score, the parental perception of infant sleep score, and the parental behavior score.
Finally, parents reported less personal sleepiness and improved mood. The Epworth sleepiness scale score improved significantly for mothers and the PHQ–2 depression screen improved for all caregivers.
This was incredibly promising. The research team and Dr. Kansagra continue to improve the prototype one iteration after the next. They added new sounds and vibration patterns to give families more options. They created an app to ensure families could track their child’s progress. And most importantly, the Lullabee algorithm now adapts and changes with the needs of each child over time. It only weans when the child is ready to become an independent sleeper. The clinical trial and family feedback were critical in helping shape Lullabee into the product it is today.