SleepNCT04697680
Efficacy of a Novel Sleep Intervention in Short Sleepers
A study testing Algorithm 1, Algorithm 2 and Algorithm 3 in people with Sleep, run by University of Arizona at 1 site in United States.
Trial summary
Approximately 1/3 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Algorithm 1, Algorithm 2 and Algorithm 3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18-60 years old
- Have a typical sleep schedule of <6 hours per night
Who cannot join
- Any condition that the PI considers would significantly impede participation in the study.
- Participant is under 18 years of age or older than 60 years of age
- Do not have a typical sleep schedule of <6 hours per night
Trial locations and contacts
1 site in 1 country.
About this study
Approximately 1/3 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 person's 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.
Read the 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 and/or 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, medication/device/procedure-focused, non-tailored approach, a successful approach for insufficient sleep will likely be out-of-clinic, population/community-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 individual's 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 person's 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.
- Conditions
- Sleep
- Being tested
- Algorithm 1, Algorithm 2, Algorithm 3
- Keywords
- Sleep Extension, Actigraphy, Sleep Diaries, Sleep Efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algorithm 1Behavioural
A sleep extension algorithm (algorithm 1) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.
Algorithm 2Behavioural
A sleep extension algorithm (algorithm 2) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.
Algorithm 3Behavioural
A sleep extension algorithm (algorithm 3) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Subjects randomized into Group 1 will be provided with a sleep schedule each week based on an algorithm (Algorithm 1) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit. Receives: Behavioral: Algorithm 1 |
| Group 2 | Active comparator | Subjects randomized into Group 2 will be provided with a sleep schedule each week based on an algorithm (Algorithm 2) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit. Receives: Behavioral: Algorithm 2 |
| Group 3 | Active comparator | Subjects randomized into Group 1 will be provided with a sleep schedule each week based on an algorithm (Algorithm 3) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit. Receives: Behavioral: Algorithm 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sleep Duration
Sleep duration will be assessed using Fitbit devices and/or sleep diaries.
Measured: Change in sleep duration from baseline and then every 7 days, over a period of 8 weeks.
Change in Sleep Efficiency
Sleep efficiency will be manually calculated using information from Fitbit devices and/or sleep diaries.
Measured: Change in sleep efficiency from baseline and then every 7 days, over a period of 8 weeks.
Secondary outcomes (21)
Change in Pittsburgh Sleep Quality Index (PSQI) scores across an eight (8) week study
The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep. In addition, a total score will be evaluated in addition to the individual items. A score of 5 has been identified as a cutoff for "poor" sleep.
Measured: Change from baseline and then at end of study [Day 57]
Change in Insomnia Severity Index (ISI) scores across an eight (8) week study
The Insomnia Severity Index (ISI) is a brief (7-item) insomnia screening tool that is the gold standard for quantifying severity of clinical insomnia symptoms.
Measured: Change from baseline and then at end of study [Day 57]
Change of Epworth Sleepiness Scale (ESS) scores across an eight (8) week study
ESS is a standard measure to assess daytime sleepiness and consists of 8 items ranging from "No chance of dozing" to "High chance of dozing" that evaluate sleep propensity in a range of situations.
Measured: Change from baseline and then at end of study [Day 57]
Change in Perceived Stress Scale (PSS) scores across an eight (8) week study
The perceived Stress Scale is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. A total score is calculated for this tool.
Measured: Change from baseline and then at end of study [Day 57]
Change in Profile of Mood States (POMS) scores across an eight (8) week study
The Profile of Mood States (POMS) is a psychological rating scale used to assess transient, distinct mood states. The POMS measures six different dimensions of mood swings over a period of time. These include: Tension or Anxiety, Anger or Hostility, Vigor or Activity, Fatigue or Inertia, Depression or Dejection, Confusion or Bewilderment. A total score will be evaluated in addition to the individual items.
Measured: Change from baseline and then at end of study [Day 57]
Change in Patient Health Questionnaire (PHQ9) scores across an eight (8) week study
PHQ9: The PHQ9 will screen for depression symptoms. It is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression: It incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Participants with a score >9 will be excluded. A total score is calculated for this tool.
Measured: Change from baseline and then at end of study [Day 57]
Change in Sleep Disorders Symptom Check List (SDSCL) scores across an eight (8) week study
The SDSCL is a 20 question instrument was developed to screen for six sleep disorders (insomnia, obstructive sleep apnea, restless legs syndrome/periodic limb movement disorder, circadian rhythm sleep-wake disorders, narcolepsy, and parasomnias) and evaluated psychometrically. Answers range from "Never" to ">5 times a week".
Measured: Change from baseline and then at end of study [Day 57]
Change in Brief Index of Sleep Control (BRISC) scores across an eight (8) week study
The BRISC is a reliable and valid screening tool to estimate self-perceived control over sleep across multiple domains. It is brief, simple, and strongly associated with overall self-reported sleep quality, insomnia, daytime sleepiness, and sleep duration. Total BRISC scores are computed as an average of item scores.
Measured: Change from baseline and then at end of study [Day 57]
Change in Generalized Anxiety Disorder 7- Item Scale scores (GAD-7) across an eight (8) week study
The GAD-7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. It contains 7 items with answers ranging from "Not at all" to "Nearly every day".
Measured: Change from baseline and then at end of study [Day 57]
Changes in The STOP-Bang questionnaire scores across an eight (8) week study
STOP-Bang is a validated screening tool for Obstructive Sleep Apnea (OSA). The higher the STOP-Bang score, the greater is the probability of moderate-to-severe OSA.
Measured: Change from baseline and then at end of study [Day 57]
Change in Positive and Negative Affect Scale (PANAS) across an eight (8) week study
PANAS: The Positive and Negative Affect Scales are brief screening measures that assess both positive and negative emotional experiences. This scale will allow for separate assessment of impact on both positive and negative mood.
Measured: Change from baseline and then at end of study [Day 57]
Change in The Circadian Energy Scale (CIRENS) scores across an eight (8) week study
CIRENS is a very short and simple chronotype measurement tool based on energy. The CIRENS consists of two introspective questions about the usual energy level (very low, low, moderate, high, or very high, scored 1 to 5) in the morning and in the evening. The difference between energy level scores (-4 to 4) felt by respondents in the evening and morning defines the chronotype score and classification.
Measured: Change from baseline and then at end of study [Day 57]
Change in the Three Factor Eating Questionnaire (TFEQ) scores across an eight (8) week study.
The Three Factor Eating Questionnaire is a validated eating behavior questionnaire that assesses eating behaviors on three subscales: cognitive restraint, emotional eating and disinhibition.
Measured: Change from baseline and then at end of study [Day 57]
Change in Assessment of Sleep Environment (ASE) scores across an eight week study.
The ASE questionnaire is a 13 item scale which assesses difficulty sleeping due to factors of sleep environment including light, temperature, and sound, with responses ranging from "Strongly Disagree" to "Strongly Agree".
Measured: Change from baseline and then at end of study [Day 57]
Changes in International Physical Activity Questionnaire (IPAQ) scores across an eight week study.
The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health related physical activity.
Measured: Change from baseline and then at end of study [Day 57]
Change in Dietary Screening Questionnaire (DSQ) scores across an eight week study.
The DSQ assesses frequency of food intake, and is provided by the National Health and Nutrition Examination Survey (NHANES).
Measured: Change from baseline and then at end of study [Day 57]
Changes in Health and Performance Questionnaire (HPQ) Question A9 scores across an eight week study.
The HPQ Question A9 is 7 items taken from the HPQ assessing work performance, with responses ranging from "All of the time" to "None of the time".
Measured: Change from baseline and then at end of study [Day 57]
Change in the Questionnaire on Use of Evening Electronics (QUEEN) scores across an eight (8) week study
The Questionnaire on Use of Evening Electronics (QUEEN) consists of 40 items assessing the use of electronic devices at night.
Measured: Change from baseline and then at end of study [Day 57]
Change in the Fatigue Severity Scale (FSS) across an eight (8) week study.
Fatigue Severity Scale (FSS) is a well-validated 9-item clinical measure that assesses overall levels of mental and physical fatigue, with answers ranging from 1- "Strongly Disagree" to 7-"Strongly Agree".
Measured: Change from baseline and then at end of study [Day 57]
Change in Work Hours and Timing Questionnaire scores across an eight (8) week Study
Work Hours and Timing Questionnaire (WHAT) is a 14-item questionnaire assessing employment status and work timing.
Measured: [Time Frame: Change from baseline and then at end of study [Day 57]
Change in Sleep Continuity questionnaire scores across an eight (8) weeks study
The Sleep Continuity questionnaire consists of 15 items and assesses sleep timing and sleep difficulties during weeknights and weekdays.
Measured: [Time Frame: Change from baseline and then at end of study [Day 57]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start15 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: COVID 2020 pandemic, unable to recruit and start study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MICHAEL A GRANDNER, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697680
- Sponsor's protocol ID
- 1812207442
- Status last verified
- Feb 2021
- First submitted
- 4 Jan 2021
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Sleep Intervention in Short Sleepers
- ClinicalTrials.gov ID
- NCT04697680
- Acronym / sponsor ID
- 1812207442
- Conditions
- Sleep
- Keywords
- Sleep Extension, Actigraphy, Sleep Diaries, Sleep Efficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID 2020 pandemic, unable to recruit and start study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 1/3 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 person's 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 and/or 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, medication/device/procedure-focused, non-tailored approach, a successful approach for insufficient sleep will likely be out-of-clinic, population/community-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 individual's 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 person's 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Behavioral: Algorithm 1Subjects randomized into Group 1 will be provided with a sleep schedule each week based on an algorithm (Algorithm 1) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit. |
| Group 2 | Active comparator | Behavioral: Algorithm 2Subjects randomized into Group 2 will be provided with a sleep schedule each week based on an algorithm (Algorithm 2) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit. |
| Group 3 | Active comparator | Behavioral: Algorithm 3Subjects randomized into Group 1 will be provided with a sleep schedule each week based on an algorithm (Algorithm 3) calculated from sleep diaries and fitbit data. Subjects will complete questionnaires at an initial clinic visit. Subjects will then complete a sleep diary upon waking each day and wear a Fitbit Charge 2 device for sleep monitoring each day for 8 weeks. At the end of the study, subjects will complete follow-up questionnaires at a final clinic visit. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Be between the ages of 18-60 years old
- Have a typical sleep schedule of <6 hours per night
Key exclusion criteria (3 listed)
- Any condition that the PI considers would significantly impede participation in the study.
- Participant is under 18 years of age or older than 60 years of age
- Do not have a typical sleep schedule of <6 hours per night
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algorithm 1A sleep extension algorithm (algorithm 1) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data. | Behavioural | Group 1 |
| Algorithm 2A sleep extension algorithm (algorithm 2) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data. | Behavioural | Group 2 |
| Algorithm 3A sleep extension algorithm (algorithm 3) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data. | Behavioural | Group 3 |
Primary outcome
Change in Sleep Duration
Time frame: Change in sleep duration from baseline and then every 7 days, over a period of 8 weeks.
Sleep duration will be assessed using Fitbit devices and/or sleep diaries.
Change in Sleep Efficiency
Time frame: Change in sleep efficiency from baseline and then every 7 days, over a period of 8 weeks.
Sleep efficiency will be manually calculated using information from Fitbit devices and/or sleep diaries.
21 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in Insomnia Severity Index (ISI) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change of Epworth Sleepiness Scale (ESS) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in Perceived Stress Scale (PSS) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in Profile of Mood States (POMS) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in Patient Health Questionnaire (PHQ9) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in Sleep Disorders Symptom Check List (SDSCL) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in Brief Index of Sleep Control (BRISC) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in Generalized Anxiety Disorder 7- Item Scale scores (GAD-7) across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Changes in The STOP-Bang questionnaire scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in Positive and Negative Affect Scale (PANAS) across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in The Circadian Energy Scale (CIRENS) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in the Three Factor Eating Questionnaire (TFEQ) scores across an eight (8) week study.
Time frame: Change from baseline and then at end of study [Day 57]
Change in Assessment of Sleep Environment (ASE) scores across an eight week study.
Time frame: Change from baseline and then at end of study [Day 57]
Changes in International Physical Activity Questionnaire (IPAQ) scores across an eight week study.
Time frame: Change from baseline and then at end of study [Day 57]
Change in Dietary Screening Questionnaire (DSQ) scores across an eight week study.
Time frame: Change from baseline and then at end of study [Day 57]
Changes in Health and Performance Questionnaire (HPQ) Question A9 scores across an eight week study.
Time frame: Change from baseline and then at end of study [Day 57]
Change in the Questionnaire on Use of Evening Electronics (QUEEN) scores across an eight (8) week study
Time frame: Change from baseline and then at end of study [Day 57]
Change in the Fatigue Severity Scale (FSS) across an eight (8) week study.
Time frame: Change from baseline and then at end of study [Day 57]
Change in Work Hours and Timing Questionnaire scores across an eight (8) week Study
Time frame: [Time Frame: Change from baseline and then at end of study [Day 57]
Change in Sleep Continuity questionnaire scores across an eight (8) weeks study
Time frame: [Time Frame: Change from baseline and then at end of study [Day 57]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm 1, Algorithm 2 and Algorithm 3 in people with Sleep, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Duration (time frame: Change in sleep duration from baseline and then every 7 days, over a period of 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.