In-Field Assessment of Sodium Oxybate Effect in Pediatric type 1 Narcolepsy: An Actigraphic Study

Marco Filardi; Fabio Pizza; Elena Antelmi; Raffaele Ferri; Vincenzo Natale; Giuseppe Plazzi

doi:10.1093/sleep/zsy050

In-Field Assessment of Sodium Oxybate Effect in Pediatric type 1 Narcolepsy: An Actigraphic Study

Marco Filardi, Fabio Pizza, Elena Antelmi, Raffaele Ferri, Vincenzo Natale, Giuseppe Plazzi

Research output: Contribution to journal › Article › peer-review

Abstract

Study Objectives: Sodium oxybate (SXB) is a GABAergic agent widely used as off-label treatment in pediatric type 1 narcolepsy (NT1). Here we aimed at analyzing by wrist actigraphy the sleep/wake profile of NT1 children and adolescents in drug-naïve condition and after 1 year of SXB treatment. As secondary aim, we investigated changes on sleepiness, cataplexy and children's anthropometric profile after 1 year of SXB treatment.

Methods: Twenty-four drug-naïve NT1 children underwent seven days of actigraphy during the school week. Information on sleepiness, narcolepsy symptoms and anthropometric features were collected during the same week with questionnaires and semi-structured clinical interview. Children started SXB treatment and underwent a second evaluation encompassing actigraphy, clinical interview, questionnaires and anthropometric assessment after 1 year of stable treatment.

Results: Actigraphy effectively documented an improvement of nocturnal sleep quality and duration coupled with a reduction of diurnal total sleep time, nap frequency and duration at 1-year follow-up. Reduction of sleepiness, cataplexy frequency and severity and weight loss, mainly in obese and overweight NT1 children, were also observed at the 1-year follow-up.

Conclusions: Actigraphy objectively documented changes in nocturnal sleep quality and diurnal napping behavior after 1-year of SXB treatment, thus representing a valid approach to ecologically assess SXB treatment effect on NT1 children's sleep/wake profile. NT1 symptoms severity and children's anthropometric features also changed as expected. Actigraphy offers the possibility to longitudinally follow up children and has potential to become a key tool to tailor treatment in pediatric patients.

Original language	English
Journal	Sleep
DOIs	https://doi.org/10.1093/sleep/zsy050
Publication status	E-pub ahead of print - Mar 7 2018

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@article{cbb503c14703407ea7562b29bb48dafa,

title = "In-Field Assessment of Sodium Oxybate Effect in Pediatric type 1 Narcolepsy: An Actigraphic Study",

abstract = "Study Objectives: Sodium oxybate (SXB) is a GABAergic agent widely used as off-label treatment in pediatric type 1 narcolepsy (NT1). Here we aimed at analyzing by wrist actigraphy the sleep/wake profile of NT1 children and adolescents in drug-na{\"i}ve condition and after 1 year of SXB treatment. As secondary aim, we investigated changes on sleepiness, cataplexy and children's anthropometric profile after 1 year of SXB treatment.Methods: Twenty-four drug-na{\"i}ve NT1 children underwent seven days of actigraphy during the school week. Information on sleepiness, narcolepsy symptoms and anthropometric features were collected during the same week with questionnaires and semi-structured clinical interview. Children started SXB treatment and underwent a second evaluation encompassing actigraphy, clinical interview, questionnaires and anthropometric assessment after 1 year of stable treatment.Results: Actigraphy effectively documented an improvement of nocturnal sleep quality and duration coupled with a reduction of diurnal total sleep time, nap frequency and duration at 1-year follow-up. Reduction of sleepiness, cataplexy frequency and severity and weight loss, mainly in obese and overweight NT1 children, were also observed at the 1-year follow-up.Conclusions: Actigraphy objectively documented changes in nocturnal sleep quality and diurnal napping behavior after 1-year of SXB treatment, thus representing a valid approach to ecologically assess SXB treatment effect on NT1 children's sleep/wake profile. NT1 symptoms severity and children's anthropometric features also changed as expected. Actigraphy offers the possibility to longitudinally follow up children and has potential to become a key tool to tailor treatment in pediatric patients.",

author = "Marco Filardi and Fabio Pizza and Elena Antelmi and Raffaele Ferri and Vincenzo Natale and Giuseppe Plazzi",

year = "2018",

month = mar,

day = "7",

doi = "10.1093/sleep/zsy050",

language = "English",

journal = "Sleep",

issn = "0161-8105",

publisher = "American Academy of Sleep Medicine",

}

TY - JOUR

T1 - In-Field Assessment of Sodium Oxybate Effect in Pediatric type 1 Narcolepsy

T2 - An Actigraphic Study

AU - Filardi, Marco

AU - Pizza, Fabio

AU - Antelmi, Elena

AU - Ferri, Raffaele

AU - Natale, Vincenzo

AU - Plazzi, Giuseppe

PY - 2018/3/7

Y1 - 2018/3/7

N2 - Study Objectives: Sodium oxybate (SXB) is a GABAergic agent widely used as off-label treatment in pediatric type 1 narcolepsy (NT1). Here we aimed at analyzing by wrist actigraphy the sleep/wake profile of NT1 children and adolescents in drug-naïve condition and after 1 year of SXB treatment. As secondary aim, we investigated changes on sleepiness, cataplexy and children's anthropometric profile after 1 year of SXB treatment.Methods: Twenty-four drug-naïve NT1 children underwent seven days of actigraphy during the school week. Information on sleepiness, narcolepsy symptoms and anthropometric features were collected during the same week with questionnaires and semi-structured clinical interview. Children started SXB treatment and underwent a second evaluation encompassing actigraphy, clinical interview, questionnaires and anthropometric assessment after 1 year of stable treatment.Results: Actigraphy effectively documented an improvement of nocturnal sleep quality and duration coupled with a reduction of diurnal total sleep time, nap frequency and duration at 1-year follow-up. Reduction of sleepiness, cataplexy frequency and severity and weight loss, mainly in obese and overweight NT1 children, were also observed at the 1-year follow-up.Conclusions: Actigraphy objectively documented changes in nocturnal sleep quality and diurnal napping behavior after 1-year of SXB treatment, thus representing a valid approach to ecologically assess SXB treatment effect on NT1 children's sleep/wake profile. NT1 symptoms severity and children's anthropometric features also changed as expected. Actigraphy offers the possibility to longitudinally follow up children and has potential to become a key tool to tailor treatment in pediatric patients.

AB - Study Objectives: Sodium oxybate (SXB) is a GABAergic agent widely used as off-label treatment in pediatric type 1 narcolepsy (NT1). Here we aimed at analyzing by wrist actigraphy the sleep/wake profile of NT1 children and adolescents in drug-naïve condition and after 1 year of SXB treatment. As secondary aim, we investigated changes on sleepiness, cataplexy and children's anthropometric profile after 1 year of SXB treatment.Methods: Twenty-four drug-naïve NT1 children underwent seven days of actigraphy during the school week. Information on sleepiness, narcolepsy symptoms and anthropometric features were collected during the same week with questionnaires and semi-structured clinical interview. Children started SXB treatment and underwent a second evaluation encompassing actigraphy, clinical interview, questionnaires and anthropometric assessment after 1 year of stable treatment.Results: Actigraphy effectively documented an improvement of nocturnal sleep quality and duration coupled with a reduction of diurnal total sleep time, nap frequency and duration at 1-year follow-up. Reduction of sleepiness, cataplexy frequency and severity and weight loss, mainly in obese and overweight NT1 children, were also observed at the 1-year follow-up.Conclusions: Actigraphy objectively documented changes in nocturnal sleep quality and diurnal napping behavior after 1-year of SXB treatment, thus representing a valid approach to ecologically assess SXB treatment effect on NT1 children's sleep/wake profile. NT1 symptoms severity and children's anthropometric features also changed as expected. Actigraphy offers the possibility to longitudinally follow up children and has potential to become a key tool to tailor treatment in pediatric patients.

U2 - 10.1093/sleep/zsy050

DO - 10.1093/sleep/zsy050

M3 - Article

C2 - 29522206

JO - Sleep

JF - Sleep

SN - 0161-8105

ER -