stops night terrors.s3.amazonaws.com/gscprogram/Expert+Call...NIGHT TERRORS ARE COMMON • Affects...

stops night terrors.

Confidential – Do Not Distribute

THE CHILDREN’S SLEEP COMPANY

LULLY

Andy Rink, MDCMO/Co-Founder

Indiana University School of Medicine - MDNorthwestern University – General Surgery Residency

Specialty Fellow, Stanford Biodesign

Mark Mahowald, MDSleep Medicine

University of Minnesota

Shannon Sullivan, MDPediatric Sleep Medicine

Stanford University

Donna McMillan, MDPediatricsPalo Alto

Medical Foundation

NIGHT TERRORS ARE COMMON

• Affects 2-12 year olds

• INCIDENCE: 3.8% = 1.5 M kids per year• PREVALENCE: 8.3% = 3.6 M kids

[1] Nguyen BH, Pérusse D, Paquet J, et al. Sleep terrors in children: a prospective study of twins. Pediatrics. 2008;122(6):e1164-7. [2] Petit D, Touchette E, Tremblay RE, Boivin M, Montplaisir J. Dyssomnias and parasomnias in early childhood. Pediatrics. 2007;119(5):e1016-25. [3] Laberge L, Tremblay RE, Vitaro F, Montplaisir J. Development of parasomnias from childhood to early adolescence. Pediatrics. 2000;106(1 Pt 1):67-74. [4] Simonds JF, Parraga H. Prevalence of sleep disorders and sleep behaviors in children and adolescents. J Am Acad Child Psychiatry. 1982 Jul;21(4):383-8. [5] Fisher HL, Lereya ST, Thompson A, Lewis G, Zammit S, Wolke D. Childhood parasomnias and psychotic experiences at age 12 years in a United kingdom birth cohort. Sleep. 2014;37(3):475-82. [6] Ohayon MM, Guilleminault C, Priest RG. Night terrors, sleepwalking, and confusional arousals in the general population: their frequency and relationship to other sleep and mental disorders. J Clin Psychiatry. 1999;60(4):268-76. [7] Bjorvatn B, Grønli J, Pallesen S. Prevalence of parasomnias in the general population. Sleep Med. 2010;11(10):1031-4.

NIGHT TERRORS

• Signs– Suddenly act in fear, pain with crying, scream– Child unresponsive to external stimuli– Amnesia for episode– Occur within 4 hours of sleep onset

[1] American Academy of Sleep Medicine. The international classification of sleep disorders, revised. 2001: 142-161.

NIGHT TERRORS

• Diagnosis– Parent history– No referral needed unless concerns for other

sleep disorder

[1] American Academy of Sleep Medicine. The international classification of sleep disorders, revised. 2001: 142-161.

CAUSE OF NIGHT TERRORS

Awake

REM

Deep

Light

one

mechanism: underlying slow wave sleep (deep sleep) abnormality

occurs each night, independent of whether a night terror will occur

[1] Zadra A, et. al. Somnambulism: clinical aspects and pathophysiological hypotheses. Lancet neurology 2013;12:285-94. [2] Guilleminault CG, et. al. NREM sleep instability in children with sleep terrors: The role of slow wave activity interruptions. Clinical Neurophysiology 2008;119:985-992.

DISCUSSION

• How often do you see a child with night terrors?

• How do you manage night terrors?

Confidential – Do Not Distribute

TREATMENT

• Education, reassurance• Scheduled awakenings

one

Confidential – Do Not Distribute

THE PROBLEM

• Scheduled awakenings– Full awakenings– Hard to know what time to do SA– Hard to remember to do it each night– Low compliance

Confidential – Do Not Distribute

THE SOLUTION:

Guide parents through SA’s

Partial awakeningPrecise timingHigh engagement

Works with behavior changes, sleep hygiene improvement

Confidential – Do Not Distribute

HOW PARENTS USE IT1. Placed under the mattress2. Answer 3 questions in Lully app

Confidential – Do Not Distribute

CLINICAL STUDY OVERVIEW

Design: Prospective study, n=12 children with severe, chronic night terrors. Nightly device use for 4 weeks

Confidential – Do Not Distribute

2 weeks 4 weeks 4 weeksBaseline Therapeutic phase (device use period) Follow up

Screening: phone screen, full history, PSQ-SDB (screen for OSA)

nightly device use, nightly sleep lognightly sleep log nightly sleep log

Outcome: Night terror reduction after 4 weeks of device use and 4 week follow up

INDIVIDUAL DATA

Confidential – Do Not Distribute

NIGHT TERROR REDUCTION

Confidential – Do Not Distribute

2 week baseline Weeks 3, 4

Mean # nt’s 14.63 3.63

SD 11.96 4.93

p 0.0051

reduction in night terror episodes (primary endpoint)

75%

CLINICAL – RESULTS

• Night terror reduction was high– After 4 weeks of device use: 75% (p=0.005)– After 4 week follow up: 88% (p=0.127)

• No serious adverse events (SAEs) reported– 1 family reported transient early rising in the

morning (qualitative)• 1 family reported nocturnal enuresis

improved with device use

Confidential – Do Not Distribute

"Un-f***ing-believable!”

“Night-terror free!!”

“I haven't known a normal night in over 2 years so thank you so much!“

“You were on our list of things to be thankful for this holiday season! You have brought so much peace to our

family. Thank you for giving us hope and peace!“

Confidential – Do Not Distribute

Edy G., Atlanta

Cathy F., Seattle

Roger P., New York

Emily H., Minneapolis

PRODUCT REVIEWS

Confidential – Do Not Distribute

WORKING WITH PARENTS

Confidential – Do Not Distribute

Provide parents with night terrors pdf and recommend product

AFFILIATE PROGRAM

• Custom affiliate link for Gentle Sleep Coaches– http://www.shareasale.com/r.cfm?B=813623&U=106

4310&M=63129&urllink=www%2Eshareasale%2Ecom%2Fshareasale%2Ecfm%3FmerchantID%3D63129

• 20% flat commission– Approx $25 for Lully Sleep Guardian original– Approx $40 for Lully Sleep Guardian Plus

CONTACT INFORMATION

• Andy Rink, MD– CMO, Lully– andy@lullysleep.com– 650-241-9154