Chronic InsomniaEarly Phase 1NCT03160404
Zolpidem or Exercise for Insomnia?
A Early Phase 1 study testing Zolpidem and Exercise in people with Chronic Insomnia, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
Introduction: The prevalence of chronic insomnia in the general population is between 10 and 15%. The therapy commonly prescribed for its treatment is pharmacological, however, there are several non-pharmacological alternatives being studied, among them physical exercise. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Zolpidem and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Apr 2018to 15 Feb 2020
- Phase
- Early Phase 1
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 30 -60 years;
- clinical diagnosis of chronic insomnia according to the DSM-V;
- insomnia complaint at least 3 times a week for at least 3 months;
- be physically inactive (exercise less than 2 times a week).
Who cannot join
- evidence that insomnia is directly related to medical conditions or side effects of medications;
- obstructive sleep apnea syndrome;
- ECG abnormalities that prevent physical exercise or use of beta-blockers;
- uncontrolled clinical diseases (diabetes, hypertension, cardiovascular, neurological or renal diseases);
- use or history of abuse of alcohol or psychoactive substances);
- use of sleeping pills> 2 times a week;
- shift workers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Zolpidem Compared With Exercise on Chronic Insomnia
Introduction: The prevalence of chronic insomnia in the general population is between 10 and 15%. The therapy commonly prescribed for its treatment is pharmacological, however, there are several non-pharmacological alternatives being studied, among them physical exercise. Although some studies have described the effect of exercise on sleep in insomnia, there are no studies comparing exercise and drugs in the treatment of chronic insomnia, or its effect as coadjuvant therapy.
Objective: To compare the acute and chronic effects of aerobic exercise and zolpidem on sleep quality, mood and quality of life in patients with chronic insomnia.
Read more
Material and Methods: 30 patients with chronic insomnia will be randomly assigned into two groups: EXERCISE (n=15) or ZOLPIDEM (n=15). The patients of EXERCISE group will be included in an aerobic exercise program, performed in 50% of reserve heart rate, on a treadmill (50 minutes, 3 times/week), during 6 weeks. The ZOLPIDEM group will be treated with zolpidem (10mg/night) during 6 weeks. Polysomnography, actigraphy, sleep diary and questionnaires will be used the evaluate sleep pattern. Mood and quality of life will be investigated by POMS and SF-36 questionnaires.
Hypothesis: Considering previous studies have demonstrated positive effects of aerobic exercise in the insomnia symptoms, the hypothesis of this study is that aerobic exercise, performed at moderate intensity, can control the symptoms of chronic insomnia similarly to pharmacological therapy.
- Conditions
- Chronic Insomnia
- Being tested
- Zolpidem, Exercise
- Keywords
- Exercise, Zolpidem, Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZolpidemDrug
The ZOLPIDEM group will be treated with zolpidem 10mg/night
ExerciseBehavioural
The EXERCISE group will participate in an aerobic exercise program, performed in intensity relative to 50% of reserve heart rate, on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| EXERCISE | Experimental | Aerobic exercise (50% Reserve heart hate), 50 minutes, 3 times/week, during 6 weeks. Receives: Behavioral: Exercise |
| ZOLPIDEM | Active comparator | 10 mg/night during 6 weeks Receives: Drug: Zolpidem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline polysomographic sleep recording to first night and 6 weeks
Polysomnografic recording include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram. Measurements of air flow (oral and nasal), respiratory effort (thoracic and abdominal), body movement, and oxygen saturation were also taken. The measured variables included total sleep time, sleep efficiency (ratio between total sleep time and total recorded time multiplied by 100), sleep onset latency, wake after sleep onset, arousals, sleep stages (N1, N2 and N3 non-rapid eye movement [non-REM] sleep and REM sleep), latencies for each sleep stage. Two researchers who were blinded to the study design performed the staging and analysed the polysomnographic events using international criteria
Measured: baseline, first night, week 6
Secondary outcomes (10)
Change from baseline actigraphy sleep recording to first night and 6 weeks
It is an objective method to evaluate sleep by movement monitoring during the night. A wrist-watch-like package is used during at least one week. Measures include sleep onset latency, wakefulness after sleep onset, time in bed (TIB), total sleep time (TST), sleep efficiency (SE), and daytime napping. The device is used to assess sleep continuously during 10-day.
Measured: baseline, first night, week 6
Change from baseline sleep diary recording to first night and 6 weeks
The sleep diary was used to evaluate the subjective perceptions of sleep. Participants were instructed to complete the diary every morning after waking for 10 days. The parameters evaluated were sleep onset latency, wake after sleep onset, total time in bed, number of arousals, sleep quality, feeling rested in the morning, and sleep efficiency (calculated retrospectively by the researchers as the ratio of reported total sleep time and reported total time in bed multiplied by 100). These data were averaged for each volunteer for pre- and post-treatment assessment weeks.
Measured: baseline, first night, week 6
Change from baseline prior sleep anxiety to first night and 6 weeks
Prior sleep state anxiety will be assessed with the State-Trait Anxiety Inventory-STAI,25 the Portuguese version of which was validated by Gorenstein and Andrade.26 This scale encompasses 20 items and provides a one-dimensional measurement of anxiety. The volunteers were instructed to answer it 30 minutes before going to sleep at baseline and at the post-exercise evaluation.
Measured: baseline, first night, week 6
Change from baseline insomnia severity to 12 weeks
Insomnia Severity Index (ISI) was administrated at baseline and post treatment to assess insomnia-related complaints. It is a short and easy self-applied scale with 7 items scored from 0 to 4, with a total score varying from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia.
Measured: baseline, week 6
Change from baseline sleep quality to 6 weeks
The PSQI assesses sleep quality over a 1-month period. The questionnaire consists of 19 self-rated questions and 5 questions that should be answered by bedmates or roommates. The latter questions are used only for clinical information. The 19 questions are categorized into 7 components, graded on a score that ranges from 0 to 3. The PSQI components are as follows: subjective sleep quality (C1), sleep latency (C2), sleep duration (C3), habitual sleep efficiency (C4), sleep disturbances (C5), use of sleeping medication (C6) and daytime dysfunction (C7). The sum of scores for these 7 components yields one global score, which ranges from 0 to 21, where the highest score indicates worst sleep quality. A global PSQI score greater than 5 indicates major difficulties in at least 2 components or moderate difficulties in more than 3 components.
Measured: baseline, week 6
Change from baseline mood to 6 weeks
The POMS questionnaire is an instrument to evaluate the acute profile of mood. It has 65 items and 6 domains: tension-anxiety, depression, anger-hostility, vigour-activity, fatigue, and confusion- bewilderment. The total mood disturbance score is derived by subtracting the vigour-activity score from the the sum of scores from the other subscales.
Measured: baseline, week 6
Change from baseline quality of life to 6 weeks
The SF-36 is a multidimensional questionnaire that covers eight components: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, vitality, general health perception, body pain, and mental health. All scores ranged from 0 to 100, with a higher score indicating better quality of life
Measured: baseline, week 6
Change from baseline serum serotonin to first night and 6 weeks
The serum serotonin dosage will be made by high performance liquid chromatography (HPLC). The blood sample will be collected at 8a.m.
Measured: baseline, first night, week 6
Change from baseline cortisol to first night and 6 weeks
The cortisol dosage will be made by chemiluminescence. The blood sample will be collected at 8 a.m.
Measured: baseline, first night, week 6
Change from baseline Effort Exercise test to 6 weeks
The test will be performed on a treadmill according to the protocol of Bruce.
Measured: baseline, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start16 Apr 2018
- Primary completion30 Dec 2019
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Goias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giselle Soares Passos, Universidade Federal de Goias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160404
- Sponsor's protocol ID
- 1.986.600
- Status last verified
- Feb 2021
- First submitted
- 4 May 2017
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Zolpidem Compared With Exercise on Chronic Insomnia
- ClinicalTrials.gov ID
- NCT03160404
- Acronym / sponsor ID
- 1.986.600
- Conditions
- Chronic Insomnia
- Keywords
- Exercise, Zolpidem, Sleep
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 19 May 2017 (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.
Introduction: The prevalence of chronic insomnia in the general population is between 10 and 15%. The therapy commonly prescribed for its treatment is pharmacological, however, there are several non-pharmacological alternatives being studied, among them physical exercise. Although some studies have described the effect of exercise on sleep in insomnia, there are no studies comparing exercise and drugs in the treatment of chronic insomnia, or its effect as coadjuvant therapy.
Objective: To compare the acute and chronic effects of aerobic exercise and zolpidem on sleep quality, mood and quality of life in patients with chronic insomnia.
Material and Methods: 30 patients with chronic insomnia will be randomly assigned into two groups: EXERCISE (n=15) or ZOLPIDEM (n=15). The patients of EXERCISE group will be included in an aerobic exercise program, performed in 50% of reserve heart rate, on a treadmill (50 minutes, 3 times/week), during 6 weeks. The ZOLPIDEM group will be treated with zolpidem (10mg/night) during 6 weeks. Polysomnography, actigraphy, sleep diary and questionnaires will be used the evaluate sleep pattern. Mood and quality of life will be investigated by POMS and SF-36 questionnaires.
Hypothesis: Considering previous studies have demonstrated positive effects of aerobic exercise in the insomnia symptoms, the hypothesis of this study is that aerobic exercise, performed at moderate intensity, can control the symptoms of chronic insomnia similarly to pharmacological therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXERCISE | Experimental | Behavioral: ExerciseAerobic exercise (50% Reserve heart hate), 50 minutes, 3 times/week, during 6 weeks. |
| ZOLPIDEM | Active comparator | Drug: Zolpidem10 mg/night during 6 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 30 -60 years;
- clinical diagnosis of chronic insomnia according to the DSM-V;
- insomnia complaint at least 3 times a week for at least 3 months;
- be physically inactive (exercise less than 2 times a week).
Key exclusion criteria (7 listed)
- evidence that insomnia is directly related to medical conditions or side effects of medications;
- obstructive sleep apnea syndrome;
- ECG abnormalities that prevent physical exercise or use of beta-blockers;
- uncontrolled clinical diseases (diabetes, hypertension, cardiovascular, neurological or renal diseases);
- use or history of abuse of alcohol or psychoactive substances);
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 |
|---|---|---|
| ZolpidemThe ZOLPIDEM group will be treated with zolpidem 10mg/night | Drug | ZOLPIDEM |
| ExerciseThe EXERCISE group will participate in an aerobic exercise program, performed in intensity relative to 50% of reserve heart rate, on a treadmill. | Behavioural | EXERCISE |
Primary outcome
Change from baseline polysomographic sleep recording to first night and 6 weeks
Time frame: baseline, first night, week 6
Polysomnografic recording include electroencephalogram, electrooculogram, electromyogram, and electrocardiogram. Measurements of air flow (oral and nasal), respiratory effort (thoracic and abdominal), body movement, and oxygen saturation were also taken. The measured variables included total sleep time, sleep efficiency (ratio between total sleep time and total recorded time multiplied by 100), sleep onset latency, wake after sleep onset, arousals, sleep stages (N1, N2 and N3 non-rapid eye movement [non-REM] sleep and REM sleep), latencies for each sleep stage. Two researchers who were blinded to the study design performed the staging and analysed the polysomnographic events using international criteria
10 secondary outcomes
Change from baseline actigraphy sleep recording to first night and 6 weeks
Time frame: baseline, first night, week 6
Change from baseline sleep diary recording to first night and 6 weeks
Time frame: baseline, first night, week 6
Change from baseline prior sleep anxiety to first night and 6 weeks
Time frame: baseline, first night, week 6
Change from baseline insomnia severity to 12 weeks
Time frame: baseline, week 6
Change from baseline sleep quality to 6 weeks
Time frame: baseline, week 6
Change from baseline mood to 6 weeks
Time frame: baseline, week 6
Change from baseline quality of life to 6 weeks
Time frame: baseline, week 6
Change from baseline serum serotonin to first night and 6 weeks
Time frame: baseline, first night, week 6
Change from baseline cortisol to first night and 6 weeks
Time frame: baseline, first night, week 6
Change from baseline Effort Exercise test to 6 weeks
Time frame: baseline, week 6
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 1 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing Zolpidem and Exercise in people with Chronic Insomnia, run by Universidade Federal de Goias at 1 site in Brazil.
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 7 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 1 Mar 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 Brazil. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from baseline polysomographic sleep recording to first night and 6 weeks (time frame: baseline, first night, week 6). 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 1 Mar 2021.