Insomnia ChronicInsomni-ExNCT04402021
Exercise and Insomnia Study: The Effects of 1 Week of Exercise Training on Insomnia Severity
A study testing Outdoor Walking and Quiet Rest in people with Insomnia Chronic and Insomnia, Primary, run by University of Pittsburgh at 1 site in United States.
Trial summary
It has been hypothesized that exercise may have a beneficial effect on sleep quality and insomnia severity in those who have insomnia symptoms as well as those who meet diagnostic criteria for insomnia disorder (e.g., Diagnostic and Statistical Manual 5th edition (DSM-5)). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Insomnia Chronic, Insomnia, Primary
- What is being tested?
- Outdoor Walking and Quiet Rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2020to 1 Dec 2020
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ISI ≥ 10
- Age 18-55 years
- Clinically defined Insomnia (i.e., meeting DSM-5 criteria for insomnia disorder)
- Psychiatric health, aside from treated anxiety and depression determined by participant self-report and instruments described below.
Who cannot join
- Unstable acute or chronic medical conditions. Examples include, but are not limited to, central nervous system disorders (e.g., head injury, seizure disorder, multiple sclerosis, tumor), cardiovascular or hemodynamically significant cardiac disease, renal failure, diabetes. Individuals with well-controlled health conditions that do not affect sleep or well-being (e.g., asthma, high blood pressure, diabetes, or ulcers) will not be excluded.
- Women who are pregnant, nursing, or are planning on becoming pregnant in the next three months.
- Current untreated major syndromal psychiatric disorders:
- Specific exclusionary self-reports include:
- Major depressive disorder
- Dysthymic disorder
Show all 36Show fewer
- Bipolar disorder
- Panic disorder
- Obsessive compulsive disorder
- Generalized anxiety disorder
- Any psychotic disorder
- Any current substance use disorder
- The investigators will NOT exclude participants for:
- Untreated subsyndromal symptoms of depression or anxiety and currently treated and stable depression or anxiety disorder.
- Past episodes of major depressive or anxiety disorder, provided the most recent episode ended at least six months before the diagnostic assessment
- Simple phobia
- Social phobia
- Past eating disorders
- Past substance use disorders
- Specific learning disabilities
- Other current sleep disorders, such as:
- Insufficient sleep syndrome
- Circadian rhythm sleep disorders
- Narcolepsy
- Restless legs syndrome
- Obstructive sleep apnea
- Current night shift work
- Other sleep disorders are diagnosed according to criteria listed in the DSM-5 and the International Classification of Sleep Disorders, 2nd Edition, 2005. These disorders are evaluated using a clinical interview with the Structured Interview for Sleep Disorders.
- > 0 on the Physical Activity Readiness Questionnaire (PAR-Q+), which represents an inability to safely perform exercise without medical approval or supervision.
- High risk of sleep-disordered breathing indicated by ≥ 5 'Yes' responses on the STOP-Bang questionnaire, or ≥ 2 + male sex, ≥2 + BMI > 35, or ≥2 + a neck circumference >16 inches (females) or >17 inches (males).
- Obesity (BMI ≥ 30)
- Indication of moderate/severe depressive or anxiety symptoms (score ≥ 10 on the Patient Health Questionnaire-9 [PHQ-9] or score ≥ 10 on the 7-item Generalized Anxiety Disorder Questionnaire [GAD-7], respectively)
- Current treatment for insomnia
- Suspected circadian rhythm disorder (delayed sleep phase: habitual bedtime ≥ 2:00 am or wake time ≥ 10:00 am; advanced sleep phase: habitual bedtime ≤ 9:00 pm or wake time ≤ 5:00 am)
- Nocturnal shift-work (i.e., working between 12:00 am and 6:00 am)
- Physically active (self-report of > 2 sessions/week of structured physical activity or >150 minutes/week of accelerometer-measured bouted moderate to vigorous physical activity)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: The Effect of Short-term Exercise on Sleep and Daytime Impairment in Adults With Insomnia
It has been hypothesized that exercise may have a beneficial effect on sleep quality and insomnia severity in those who have insomnia symptoms as well as those who meet diagnostic criteria for insomnia disorder (e.g., Diagnostic and Statistical Manual 5th edition (DSM-5)). Yet, the studies that have tested this are extremely limited in number and even fewer explore any acute effects of exercise training on subjects who meet diagnostic criteria. Thus, the investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia.
Read the detailed description
Limited experimental research has explored the effects of acute exercise training (< 1 week of exercise) on sleep and daytime impairment in samples of adults who meet diagnostic criteria for insomnia. In response to the current literature, the investigators aim to better understand the short-term clinical benefit of adopting exercise training in insomnia. Including multiple bouts of exercise in a short time span while measuring sleep with objective and self-reported measures may be more reflective of capturing true acute effects of exercise implementation on insomnia. The investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia. This project will address prior limitations in the area of acute exercise research by utilizing a sample with diagnosed insomnia, assessing multiple nights of sleep, and implementing multiple bouts of exercise stimuli. This project will examine the following aims:
Aim 1: To examine if implementing 1 week of moderate-intensity aerobic exercise improves objective and subjective sleep compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.
Aim 2: To examine if implementing 1 week of moderate-intensity aerobic exercise reduces severity of daytime impairment compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.
- Conditions
- Insomnia Chronic, Insomnia, Primary
- Being tested
- Outdoor Walking, Quiet Rest
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor WalkingBehavioural
Unsupervised outdoor walking will be the mode used for moderate-intensity aerobic exercise. The walking intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.
Quiet RestOther
The quiet rest condition will consist of watching a nature documentary in a quiet room. The quiet rest intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Participants randomized to the aerobic exercise group will complete 30 minutes of outdoor walking at a moderate intensity, defined as 50% heart rate reserve from the American College of Sports Medicine (ACSM) exercise prescription recommendations. A 5-minute warm-up and cool-down will occur before and after the 30-minute bout. A Polar H10 heart rate monitor will continuously monitor exercise intensity during the session. Ratings of Perceived Exertion (RPE) will be assessed using the Borg scale (i.e., 6-20 rating system) to indicate perceived exercise effort every 5 minutes during the exercise session. Each session will last approximately 50 minutes. Receives: Behavioral: Outdoor Walking |
| Quiet Rest | Other | Participants randomized to this condition will be instructed to watch a nature documentary void of topics related to sleep or exercise. A Polar H10 heart rate monitor will continuously monitor heart rate during the session to mimic the aerobic exercise condition. Participants will not be permitted to complete homework or work during the allotted time to reduce the chance of unintended stimuli. The quiet rest sessions will be 50 minutes in length. Receives: Other: Quiet Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sleep Efficiency (SE)
Mean SE derived from wrist-worn actigraphy (7 nights of data)
Measured: Change in SE between baseline and intervention week (approx. 2 weeks)
PROMIS Sleep Disturbance Questionnaire (PROMIS SD) score
A 5-point Likert scale composed of eight items rated from 1 (not at all, very poor, or never) to 5 (very much, always, or very good) with four items reversed scored. Total raw scores range from 8 to 40 with higher scores indicating greater disturbance. Raw scores will be converted to corresponding T-scores using a published data conversion table.
Measured: Change in PROMIS SD between baseline and intervention week (approx. 2 weeks)
Secondary outcomes (2)
Insomnia Severity Index (ISI) score
A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28.
Measured: Change in ISI between baseline and intervention week (approx. 2 weeks)
PROMIS Sleep Related Impairment Questionnaire (PROMIS SRI) score
A 5-point Likert scale composed of 8 items rated from 1 (not at all) to 5 (very much). One of the eight items (I felt alert when I woke up) is reverse scored. A total score from 8 to 40 is computed with higher scores indicating worse impairment. Total raw scores range from 8 to 40 with higher scores indicating greater disturbance. Raw scores will be converted to corresponding T-scores using a published data conversion table.
Measured: Change in PROMIS SRI between baseline and intervention week (approx. 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start11 Aug 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Kubala, University of Pittsburgh
- Investigators
- Andrew Kubala, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402021
- Sponsor's protocol ID
- STUDY20010197
- Acronym
- Insomni-Ex
- Status last verified
- Jan 2021
- First submitted
- 11 May 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified data that are relevant to the primary aims of the study will be provided to external investigators along with a relevant data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short-term Exercise on Sleep and Daytime Impairment in Adults With Insomnia
- ClinicalTrials.gov ID
- NCT04402021
- Acronym / sponsor ID
- Insomni-Ex / STUDY20010197
- Conditions
- Insomnia Chronic, Insomnia, Primary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 26 May 2020 (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.
It has been hypothesized that exercise may have a beneficial effect on sleep quality and insomnia severity in those who have insomnia symptoms as well as those who meet diagnostic criteria for insomnia disorder (e.g., Diagnostic and Statistical Manual 5th edition (DSM-5)). Yet, the studies that have tested this are extremely limited in number and even fewer explore any acute effects of exercise training on subjects who meet diagnostic criteria. Thus, the investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia.
Detailed description
Limited experimental research has explored the effects of acute exercise training (< 1 week of exercise) on sleep and daytime impairment in samples of adults who meet diagnostic criteria for insomnia. In response to the current literature, the investigators aim to better understand the short-term clinical benefit of adopting exercise training in insomnia. Including multiple bouts of exercise in a short time span while measuring sleep with objective and self-reported measures may be more reflective of capturing true acute effects of exercise implementation on insomnia. The investigators propose to conduct a randomized parallel design to compare the effects of short-term moderate-intensity aerobic exercise on insomnia severity and measures of sleep in a sample of adults who meet diagnostic criteria for insomnia. This project will address prior limitations in the area of acute exercise research by utilizing a sample with diagnosed insomnia, assessing multiple nights of sleep, and implementing multiple bouts of exercise stimuli. This project will examine the following aims:
Aim 1: To examine if implementing 1 week of moderate-intensity aerobic exercise improves objective and subjective sleep compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.
Aim 2: To examine if implementing 1 week of moderate-intensity aerobic exercise reduces severity of daytime impairment compared to 1 week without exercise in a sample of adults who meet diagnostic criteria for insomnia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Outdoor WalkingParticipants randomized to the aerobic exercise group will complete 30 minutes of outdoor walking at a moderate intensity, defined as 50% heart rate reserve from the American College of Sports Medicine (ACSM) exercise prescription recommendations. A 5-minute warm-up and cool-down will occur before and after the 30-minute bout. A Polar H10 heart rate monitor will continuously monitor exercise intensity during the session. Ratings of Perceived Exertion (RPE) will be assessed using the Borg scale (i.e., 6-20 rating system) to indicate perceived exercise effort every 5 minutes during the exercise session. Each session will last approximately 50 minutes. |
| Quiet Rest | Other | Other: Quiet RestParticipants randomized to this condition will be instructed to watch a nature documentary void of topics related to sleep or exercise. A Polar H10 heart rate monitor will continuously monitor heart rate during the session to mimic the aerobic exercise condition. Participants will not be permitted to complete homework or work during the allotted time to reduce the chance of unintended stimuli. The quiet rest sessions will be 50 minutes in length. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ISI ≥ 10
- Age 18-55 years
- Clinically defined Insomnia (i.e., meeting DSM-5 criteria for insomnia disorder)
- Psychiatric health, aside from treated anxiety and depression determined by participant self-report and instruments described below.
Key exclusion criteria (36 listed)
- Unstable acute or chronic medical conditions. Examples include, but are not limited to, central nervous system disorders (e.g., head injury, seizure disorder, multiple sclerosis, tumor), cardiovascular or hemodynamically significant cardiac disease, renal failure, diabetes. Individuals with well-controlled health conditions that do not affect sleep or well-being (e.g., asthma, high blood pressure, diabetes, or ulcers) will not be excluded.
- Women who are pregnant, nursing, or are planning on becoming pregnant in the next three months.
- Current untreated major syndromal psychiatric disorders:
- Other current sleep disorders, such as:
- Other sleep disorders are diagnosed according to criteria listed in the DSM-5 and the International Classification of Sleep Disorders, 2nd Edition, 2005. These disorders are evaluated using a clinical interview with the Structured Interview for Sleep Disorders.
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 |
|---|---|---|
| Outdoor WalkingUnsupervised outdoor walking will be the mode used for moderate-intensity aerobic exercise. The walking intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning. | Behavioural | Aerobic Exercise |
| Quiet RestThe quiet rest condition will consist of watching a nature documentary in a quiet room. The quiet rest intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning. | Other | Quiet Rest |
Primary outcome
Mean Sleep Efficiency (SE)
Time frame: Change in SE between baseline and intervention week (approx. 2 weeks)
Mean SE derived from wrist-worn actigraphy (7 nights of data)
PROMIS Sleep Disturbance Questionnaire (PROMIS SD) score
Time frame: Change in PROMIS SD between baseline and intervention week (approx. 2 weeks)
A 5-point Likert scale composed of eight items rated from 1 (not at all, very poor, or never) to 5 (very much, always, or very good) with four items reversed scored. Total raw scores range from 8 to 40 with higher scores indicating greater disturbance. Raw scores will be converted to corresponding T-scores using a published data conversion table.
2 secondary outcomes
Insomnia Severity Index (ISI) score
Time frame: Change in ISI between baseline and intervention week (approx. 2 weeks)
PROMIS Sleep Related Impairment Questionnaire (PROMIS SRI) score
Time frame: Change in PROMIS SRI between baseline and intervention week (approx. 2 weeks)
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 14 Jan 2021.
- Individual participant dataSharing planned: Yes. Individual deidentified data that are relevant to the primary aims of the study will be provided to external investigators along with a relevant data dictionary.
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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.
Andrew Kubala, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor Walking and Quiet Rest in people with Insomnia Chronic and Insomnia, Primary, run by University of Pittsburgh 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 4 inclusion and 36 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 14 Jan 2021. 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?
Mean Sleep Efficiency (SE) (time frame: Change in SE between baseline and intervention week (approx. 2 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 14 Jan 2021.