Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697680
Status:
UNKNOWN
Last Update Posted:
2021-02-12
First Post:
2021-01-04
Brief Title:
Efficacy of a Novel Sleep Intervention in Short Sleepers
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Efficacy of a Novel Sleep Intervention in Short Sleepers
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 13 of Americans sleep 6h per night an amount that has been deemed sub-optimal by the American Academy of Sleep Medicine and Sleep Research Society the National Sleep Foundation American Thoracic Society and the American Heart Association These consensus statements echo findings from many reviews on this topic This is alarming given epidemiologic and experimental research showing that reduced sleep time is associated with a variety of negative health outcomes including obesity diabetes cardiovascular disease and mortality Different people may need different amounts of sleep And some people may not be able to make large changes to their sleep schedule all at once Many individuals have situational constraints that change over time As such short sleep represents an unmet public health problem There are however no empirically supported interventions for insufficient sleep The proposed study addresses this critical gap by evaluating the efficacy of a novel intervention that is theoretically grounded feasible and has positive impacts on sleep duration The intervention in the proposed study is by design self-correcting individually-tailored and not dependent on unknown individual sleep needs It can adapt to any schedule and situation and can adapt to changes in a persons sleep schedule The main goal of this study is to evaluate whether a manually determined sleep extension intervention is effective at improving sleep and related outcomes among adults who find it difficult to get enough sleep
Detailed Description:
Approximately 35 of Americans sleep 6h per night an amount that has been deemed sub-optimal by the American Academy of Sleep Medicine and Sleep Research Society the National Sleep Foundation American Thoracic Society and the American Heart Association These consensus statements echo findings from many reviews on this topic This is alarming given epidemiologic and experimental research showing that reduced sleep time is associated with a variety of negative health outcomes including obesity diabetes cardiovascular disease and mortality As such short sleep represents an unmet public health problem There are however no empirically supported interventions for insufficient sleep The proposed study addresses this critical gap by evaluating the efficacy of a novel intervention that is theoretically grounded feasible and has positive impacts on sleep duration
Previous studies have associated habitual short sleep duration with important adverse cardiometabolic outcomes including weight gain obesity diabetes cardiovascular disease stress etc They suggest that those that report short sleep may be more likely to experience functional impairments and are less likely to engage in behaviors consistent with a healthy lifestyle A proposed mechanism of these relationships is that insufficient sleep duration triggers metabolic disturbances and increased immune response resulting in appetite dysregulation adverse cardiovascular outcomes and resultant disease states In addition to cardiometabolic effects behavioral and functional consequences of short sleep have been well-documented For example short sleepers are more likely to exhibit difficulties initiating andor maintaining sleep daytime sleepiness drowsy driving and other impairments as a result of sleep loss Laboratory studies have extensively documented neurocognitive and behavioral effects of sleep loss including increased objective sleepiness impaired vigilance using computer-based psychomotor assessments and deficits in working memory decision-making and executive function as assessed using standardized neuropsychologic and neuroimaging techniques
Most if not all sleep disorders have targeted interventions Interventions have not been developed or evaluated for insufficient sleep An effective and disseminable intervention for insufficient sleep will likely differ from those of sleep disorders- rather than an in-clinic visit-based medicationdeviceprocedure-focused non-tailored approach a successful approach for insufficient sleep will likely be out-of-clinic populationcommunity-based lifestyle-focused and individually-tailored The problem of insufficient sleep is less like other sleep disorders and more like other health behaviors such as smoking poor diet and lack of physical activity in that the reasons for insufficient sleep involve beliefs and attitudes home and work demands and environmental constraints
With this in mind a behavioral intervention was developed based on concepts originally implemented in Cognitive Behavioral Therapy for Insomnia CBTI the most well-supported treatment approach for insomnia Although CBTI does not routinely increase sleep duration it has sleep efficiency as its primary endpoint and employs concepts that can potentially be used to increase sleep time while maintaining high levels of sleep efficiency The intervention originally developed included algorithms that recognize the natural ebb and flow of sleep ability within an individual seek to use an individuals own sleep data to predict 1 when is an optimal time to make a change to sleep and 2 what sort of incremental change should be made with the eventual goal of increasing sleep efficiency and duration
Different people may need different amounts of sleep And some people may not be able to make large changes to their sleep schedule all at once Many individuals have situational constraints that change over time The intervention in the proposed study is by design self-correcting individually-tailored and not dependent on unknown individual sleep needs It can adapt to any schedule and situation and can adapt to changes in a persons sleep schedule
This sleep extension intervention specifically uses a novel approach where individualized feedback will be provided to each participant based on information provided by the wearable devices and the sleep diary The goal is recognizing the optimal time to make a change to sleep patterns and deciding what kind of change should be made
Previous studies have associated habitual short sleep duration with important adverse cardiometabolic outcomes including weight gain obesity diabetes cardiovascular disease stress etc They suggest that those that report short sleep may be more likely to experience functional impairments and are less likely to engage in behaviors consistent with a healthy lifestyle A proposed mechanism of these relationships is that insufficient sleep duration triggers metabolic disturbances and increased immune response resulting in appetite dysregulation adverse cardiovascular outcomes and resultant disease states In addition to cardiometabolic effects behavioral and functional consequences of short sleep have been well-documented For example short sleepers are more likely to exhibit difficulties initiating andor maintaining sleep daytime sleepiness drowsy driving and other impairments as a result of sleep loss Laboratory studies have extensively documented neurocognitive and behavioral effects of sleep loss including increased objective sleepiness impaired vigilance using computer-based psychomotor assessments and deficits in working memory decision-making and executive function as assessed using standardized neuropsychologic and neuroimaging techniques
Most if not all sleep disorders have targeted interventions Interventions have not been developed or evaluated for insufficient sleep An effective and disseminable intervention for insufficient sleep will likely differ from those of sleep disorders- rather than an in-clinic visit-based medicationdeviceprocedure-focused non-tailored approach a successful approach for insufficient sleep will likely be out-of-clinic populationcommunity-based lifestyle-focused and individually-tailored The problem of insufficient sleep is less like other sleep disorders and more like other health behaviors such as smoking poor diet and lack of physical activity in that the reasons for insufficient sleep involve beliefs and attitudes home and work demands and environmental constraints
With this in mind a behavioral intervention was developed based on concepts originally implemented in Cognitive Behavioral Therapy for Insomnia CBTI the most well-supported treatment approach for insomnia Although CBTI does not routinely increase sleep duration it has sleep efficiency as its primary endpoint and employs concepts that can potentially be used to increase sleep time while maintaining high levels of sleep efficiency The intervention originally developed included algorithms that recognize the natural ebb and flow of sleep ability within an individual seek to use an individuals own sleep data to predict 1 when is an optimal time to make a change to sleep and 2 what sort of incremental change should be made with the eventual goal of increasing sleep efficiency and duration
Different people may need different amounts of sleep And some people may not be able to make large changes to their sleep schedule all at once Many individuals have situational constraints that change over time The intervention in the proposed study is by design self-correcting individually-tailored and not dependent on unknown individual sleep needs It can adapt to any schedule and situation and can adapt to changes in a persons sleep schedule
This sleep extension intervention specifically uses a novel approach where individualized feedback will be provided to each participant based on information provided by the wearable devices and the sleep diary The goal is recognizing the optimal time to make a change to sleep patterns and deciding what kind of change should be made
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None