Attention Deficit Hyperactivity DisorderNCT02732756
Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD
A study testing Healthy Sleep Duration and Shortened Sleep Duration in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Adolescents with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their typically developing peers. Observational studies indicate that inadequate sleep is correlated with impairment in adolescents with ADHD, but it remains unknown if sleep is causally related to impairment. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Healthy Sleep Duration and Shortened Sleep Duration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2016to 25 Aug 2017
- 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 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 14 and 17 years of age.
- Estimated IQ ≥ 70.
- Meet full DSM-5 criteria for ADHD.
- Sufficient English language ability necessary to complete study measures.
- If applicable, the family must be willing to discontinue any treatment with a psychostimulant medication during the three-week sleep manipulation protocol.
Who cannot join
- Children with an autism spectrum disorder or diagnosed with psychosis, bipolar disorder, or obsessive-compulsive disorder based on the K-SADS diagnostic interview will be excluded.
- Children taking any psychiatric medication that is not a psychostimulant.
- Significant visual, hearing, or speech impairment.
- Organic brain injury or history of seizures.
- Symptoms of obstructive sleep apnea (OSA), periodic limb movement disorder (PLMD), or delayed sleep phase syndrome (DSPS).
- Obligations that require bedtime later than 10pm or waking prior to 5:30am any morning of the study.
Show all 10Show fewer
- Daily consumption of >1 coffee or "energy drink" or >3 caffeinated sodas.
- Highly atypical sleep, defined as <6 hours or >9.5 hours on school nights per parent and adolescent report.
- Inability or refusal to refrain from automobile driving or other high-risk tasks that require vigilance during the sleep restriction week of the study.
- Finally, at the visit following the baseline week (week 1) of the sleep protocol, we will exclude teens whose actigraphs reflect an inability to consistently arise within 1 hour of the agreed-upon time.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Adolescents with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their typically developing peers. Observational studies indicate that inadequate sleep is correlated with impairment in adolescents with ADHD, but it remains unknown if sleep is causally related to impairment. This study will use an experimental sleep restriction and extension protocol to evaluate sleep as a contributor to clinically significant impairment and possible target for intervention in adolescents with ADHD.
Read the detailed description
Teens with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their peers, with up to 75% of youth with ADHD obtaining insufficient sleep. This is noteworthy since insufficient sleep is associated with a multitude of negative outcomes in typically developing teens, including academic underachievement, emotion dysregulation, and mental health problems - all outcomes that occur at higher rates among teens with ADHD. Our pilot work demonstrates that insufficient sleep is correlated with depression, behavior problems, and academic impairment in teens with ADHD specifically and insufficient sleep is clearly associated with greater attentional problems in typical teens. However, no experimental study has examined whether sleep duration is causally linked to attentional, behavioral, emotional, and academic impairments in teens diagnosed with ADHD. If sleep problems contribute to functional impairments in teens with ADHD, then they represent an overlooked treatment target. Experimental studies provide the strongest test of causality, and studies using at-home sleep restriction protocols in teens without ADHD show a causal link between shortened sleep duration and impairment. However, administering an at-home sleep restriction protocol may be especially challenging for teens with ADHD due to their difficulties with organizing bedtime and wake activities, as well as differences from healthy teens in biological circadian preference. Thus, a critical first step in examining sleep as causally related to impairment in teens with ADHD is documenting the feasibility of using an at-home sleep restriction protocol with this population. This study will (1) evaluate the feasibility of using an at-home sleep restriction protocol in teens with ADHD, and (2) collect preliminary data examining whether shortened sleep duration is causally linked to attentional, behavioral, emotional, and academic impairment in teens with ADHD. These goals will be accomplished by recruiting 54 teens with ADHD who will undergo a three-week sleep manipulation protocol. Specifically, a cross-over design will be used that includes a week of typical sleep followed by weeks of sleep restriction or sleep extension. Sleep functioning will be assessed during these three weeks with daily sleep diary and objective sleep measurement (i.e., actigraphy). After each sleep condition, teens and their parents will complete subjective and objective measures of attention, behavior, mood, and academics. Findings from this study will allow us to identify and address barriers to administering an at-home sleep restriction and extension protocol to teens with ADHD and pursue larger-scale experimental research examining sleep problems as causally linked to impairment. This research is clinically significant since teens with ADHD frequently experience a range of impairments that extend well into adulthood. If short sleep duration contributes to functional impairments in teens with ADHD, then sleep represents a modifiable and overlooked treatment target.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Healthy Sleep Duration, Shortened Sleep Duration
- Keywords
- ADHD, Sleep, Attention, Adolescence
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Sleep DurationBehavioural
This study examines healthy sleep duration as related to improved functioning in adolescents with ADHD. Adolescent participants will be instructed to go to bed at a time such that they are able to obtain 9 hours of nightly sleep (9.5 hours in bed, leaving up to ½ hour to fall asleep). Researchers will work with the adolescent and their family to problem-solve how to accomplish this sleep duration goal.
Shortened Sleep DurationBehavioural
This study examines shortened sleep duration as related to poorer functioning in adolescents with ADHD. Adolescent participants will be instructed to go to bed at a time such that they are in bed for 6.5 hours per night. Researchers will work with the adolescent and their family to problem-solve how to accomplish this sleep duration goal.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Restriction | Experimental | The Sleep Restriction condition will allow 6.5 hours in bed, which in previous research results in an average of 6.1-6.3 hours of nightly sleep. This condition reflects a realistic dose of sleep restriction (similar to the school-night sleep of 15-20% of healthy adolescents) that has been shown to be feasible and to induce daytime sleepiness, inattention, and irritability/moodiness in typically developing adolescents. Receives: Behavioral: Shortened Sleep Duration |
| Sleep Extension | Experimental | The Sleep Extension condition will allow adolescents to obtain 9 hours of nightly sleep (9.5 hours in bed, leaving up to ½ hour to fall asleep), which (a) is how long adolescents sleep during controlled trials of sleep satiation and naturally on non-school nights, (b) has been shown to result in a well-rested state, and (c) matches clinical recommendations for adolescents. Receives: Behavioral: Healthy Sleep Duration |
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 with actigraphy for five days during each sleep restriction/extension experimental arm. The sleep duration outcome will be assessed as the change in average nightly sleep duration between the sleep restriction and sleep extension arms.
Measured: Following each of the two arms that each last one week.
Secondary outcomes (5)
Change in ADHD symptoms
ADHD symptoms will be assessed using parent and adolescent ratings at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The ADHD symptom outcome will be assessed as the change in ADHD symptoms between the two week-long experimental arms.
Measured: Following each of the two arms that each last one week.
Change in internalizing symptoms
Internalizing symptoms will be assessed using parent and adolescent ratings at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The internalizing outcome will be assessed as the change in internalizing symptoms between the two week-long experimental arms.
Measured: Following each of the two arms that each last one week.
Change in behavioral functioning
Oppositional symptoms will be assessed using parent ratings at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The oppositional behavior outcome will be assessed as the change in oppositional behaviors between the two week-long experimental arms.
Measured: Following each of the two arms that each last one week.
Change in cognitive functioning
Cognitive functioning will be assessed using neuropsychological test performance at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The outcome will be assessed as the change in neuropsychological test performance between the two week-long experimental arms.
Measured: Following each of the two arms that each last one week.
Change in emotion regulation
Emotion regulation will be assessed using parent and adolescent ratings at the end of each five-day period following each sleep restriction (Week A) and sleep extension (Week B) experimental arm. The emotion regulation outcome will be assessed as the change in emotion regulation between the two week-long experimental arms.
Measured: Following each of the two arms that each last one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start21 Apr 2016
- Primary completion25 Aug 2017
- Study completion25 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732756
- Sponsor's protocol ID
- CIN_ADHDsleep_001
- Status last verified
- Oct 2017
- First submitted
- 24 Mar 2016
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Becker SP, Epstein JN, Tamm L, Tilford AA, Tischner CM, Isaacson PA, Simon JO, Beebe DW. Shortened Sleep Duration Causes Sleepiness, Inattention, and Oppositionality in Adolescents With Attention-Deficit/Hyperactivity Disorder: Findings From a Crossover Sleep Restriction/Extension Study. J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):433-442. doi: 10.1016/j.jaac.2018.09.439. Epub 2018 Nov 2.
PubMed 30768404
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Behavioral Effects of Sleep Restriction in Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT02732756
- Acronym / sponsor ID
- CIN_ADHDsleep_001
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Sleep, Attention, Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 25 Aug 2017 (actual)
- Study completion
- 25 Aug 2017 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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.
Adolescents with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their typically developing peers. Observational studies indicate that inadequate sleep is correlated with impairment in adolescents with ADHD, but it remains unknown if sleep is causally related to impairment. This study will use an experimental sleep restriction and extension protocol to evaluate sleep as a contributor to clinically significant impairment and possible target for intervention in adolescents with ADHD.
Detailed description
Teens with attention-deficit/hyperactivity disorder (ADHD) obtain less sleep than their peers, with up to 75% of youth with ADHD obtaining insufficient sleep. This is noteworthy since insufficient sleep is associated with a multitude of negative outcomes in typically developing teens, including academic underachievement, emotion dysregulation, and mental health problems - all outcomes that occur at higher rates among teens with ADHD. Our pilot work demonstrates that insufficient sleep is correlated with depression, behavior problems, and academic impairment in teens with ADHD specifically and insufficient sleep is clearly associated with greater attentional problems in typical teens. However, no experimental study has examined whether sleep duration is causally linked to attentional, behavioral, emotional, and academic impairments in teens diagnosed with ADHD. If sleep problems contribute to functional impairments in teens with ADHD, then they represent an overlooked treatment target. Experimental studies provide the strongest test of causality, and studies using at-home sleep restriction protocols in teens without ADHD show a causal link between shortened sleep duration and impairment. However, administering an at-home sleep restriction protocol may be especially challenging for teens with ADHD due to their difficulties with organizing bedtime and wake activities, as well as differences from healthy teens in biological circadian preference. Thus, a critical first step in examining sleep as causally related to impairment in teens with ADHD is documenting the feasibility of using an at-home sleep restriction protocol with this population. This study will (1) evaluate the feasibility of using an at-home sleep restriction protocol in teens with ADHD, and (2) collect preliminary data examining whether shortened sleep duration is causally linked to attentional, behavioral, emotional, and academic impairment in teens with ADHD. These goals will be accomplished by recruiting 54 teens with ADHD who will undergo a three-week sleep manipulation protocol. Specifically, a cross-over design will be used that includes a week of typical sleep followed by weeks of sleep restriction or sleep extension. Sleep functioning will be assessed during these three weeks with daily sleep diary and objective sleep measurement (i.e., actigraphy). After each sleep condition, teens and their parents will complete subjective and objective measures of attention, behavior, mood, and academics. Findings from this study will allow us to identify and address barriers to administering an at-home sleep restriction and extension protocol to teens with ADHD and pursue larger-scale experimental research examining sleep problems as causally linked to impairment. This research is clinically significant since teens with ADHD frequently experience a range of impairments that extend well into adulthood. If short sleep duration contributes to functional impairments in teens with ADHD, then sleep represents a modifiable and overlooked treatment target.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Restriction | Experimental | Behavioral: Shortened Sleep DurationThe Sleep Restriction condition will allow 6.5 hours in bed, which in previous research results in an average of 6.1-6.3 hours of nightly sleep. This condition reflects a realistic dose of sleep restriction (similar to the school-night sleep of 15-20% of healthy adolescents) that has been shown to be feasible and to induce daytime sleepiness, inattention, and irritability/moodiness in typically developing adolescents. |
| Sleep Extension | Experimental | Behavioral: Healthy Sleep DurationThe Sleep Extension condition will allow adolescents to obtain 9 hours of nightly sleep (9.5 hours in bed, leaving up to ½ hour to fall asleep), which (a) is how long adolescents sleep during controlled trials of sleep satiation and naturally on non-school nights, (b) has been shown to result in a well-rested state, and (c) matches clinical recommendations for adolescents. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between 14 and 17 years of age.
- Estimated IQ ≥ 70.
- Meet full DSM-5 criteria for ADHD.
- Sufficient English language ability necessary to complete study measures.
- If applicable, the family must be willing to discontinue any treatment with a psychostimulant medication during the three-week sleep manipulation protocol.
Key exclusion criteria (10 listed)
- Children with an autism spectrum disorder or diagnosed with psychosis, bipolar disorder, or obsessive-compulsive disorder based on the K-SADS diagnostic interview will be excluded.
- Children taking any psychiatric medication that is not a psychostimulant.
- Significant visual, hearing, or speech impairment.
- Organic brain injury or history of seizures.
- Symptoms of obstructive sleep apnea (OSA), periodic limb movement disorder (PLMD), or delayed sleep phase syndrome (DSPS).
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 |
|---|---|---|
| Healthy Sleep DurationThis study examines healthy sleep duration as related to improved functioning in adolescents with ADHD. Adolescent participants will be instructed to go to bed at a time such that they are able to obtain 9 hours of nightly sleep (9.5 hours in bed, leaving up to ½ hour to fall asleep). Researchers will work with the adolescent and their family to problem-solve how to accomplish this sleep duration goal. | Behavioural | Sleep Extension |
| Shortened Sleep DurationThis study examines shortened sleep duration as related to poorer functioning in adolescents with ADHD. Adolescent participants will be instructed to go to bed at a time such that they are in bed for 6.5 hours per night. Researchers will work with the adolescent and their family to problem-solve how to accomplish this sleep duration goal. | Behavioural | Sleep Restriction |
Primary outcome
Change in sleep duration
Time frame: Following each of the two arms that each last one week.
Sleep duration will be assessed with actigraphy for five days during each sleep restriction/extension experimental arm. The sleep duration outcome will be assessed as the change in average nightly sleep duration between the sleep restriction and sleep extension arms.
5 secondary outcomes
Change in ADHD symptoms
Time frame: Following each of the two arms that each last one week.
Change in internalizing symptoms
Time frame: Following each of the two arms that each last one week.
Change in behavioral functioning
Time frame: Following each of the two arms that each last one week.
Change in cognitive functioning
Time frame: Following each of the two arms that each last one week.
Change in emotion regulation
Time frame: Following each of the two arms that each last one week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Derived from this study: PubMed 30768404Becker SP, Epstein JN, Tamm L, Tilford AA, Tischner CM, Isaacson PA, Simon JO, Beebe DW. Shortened Sleep Duration Causes Sleepiness, Inattention, and Oppositionality in Adolescents With Attention-Deficit/Hyperactivity Disorder: Findings From a Crossover Sleep Restriction/Extension Study. J Am Acad Child Adolesc Psychiatry. 2019 Apr;58(4):433-442. doi: 10.1016/j.jaac.2018.09.439. Epub 2018 Nov 2.
- Individual participant dataSharing planned: No
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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 Healthy Sleep Duration and Shortened Sleep Duration in people with Attention Deficit Hyperactivity Disorder, run by Children's Hospital Medical Center, Cincinnati 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 12 Oct 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Following each of the two arms that each last one week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02732756, which also lists 1 linked publication.
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 12 Oct 2017.