Chronic InsomniaNCT03171519
Effects of Exercise and Acupuncture on Chronic Insomnia
A study testing Exercise and Acupuncture in people with Chronic Insomnia, run by Universidade Federal de Goias at 1 site in Brazil.
Trial summary
Introduction: Chronic insomnia is a sleep disorder, characterized by difficulty in initiating and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at least 3 months. 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?
- Exercise and Acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2017to 15 May 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 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 (performed by a physician specialized in Sleep Medicine);
- 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 os 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: Effects of Exercise and Acupuncture on Chronic Insomnia: a Randomized Control Trial
Introduction: Chronic insomnia is a sleep disorder, characterized by difficulty in initiating and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at least 3 months. Pharmacologic therapy is the most commonly method used for its treatment, however, pharmacotherapy is associated with side effects. Thus, non-pharmacological therapies have been suggested as an alternative. Objective: To verify the effects of exercise associated with acupuncture on chronic insomnia. METHODS: 40 patients with chronic insomnia will be randomly assigned into two groups: CONTROL (n = 20) and ACUPUNCTURE (n = 20). The volunteers of the CONTROL group will be submitted to 12 weeks of aerobic exercise, performed on a treadmill, with frequency of 3 times / week and duration of 50 minutes / day. ACUPUNCTURE volunteers will perform aerobic exercise, following the protocol of the CONTROL group, plus acupuncture therapy once a week. The sleep evaluation will be evaluated by polysomnography and questionnaires. Expected Results: A 12-week combined therapy could potentiate the previously described positive effects of exercise in the treatment of chronic insomnia.
- Conditions
- Chronic Insomnia
- Being tested
- Exercise, Acupuncture
- Keywords
- Physical activity, Disorders of onset and maintenance of sleep, non-pharmacological treatment, Acupuncture
- 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.
ExerciseBehavioural
The EXERCISE group will participate in an aerobic exercise program for 12 weeks, performed in intensity relative to 50% of reserve heart rate, on a treadmill.
AcupunctureBehavioural
The ACUPUNCTURE group will participate in an aerobic exercise program following the protocol of the EXERCISE group, plus acupuncture therapy once a week.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Active comparator | Not described Receives: Behavioral: Exercise |
| Exercise + acupuncture | Experimental | Not described Receives: Behavioral: Exercise; Behavioral: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline polysomnography to 12 weeks
Polysomnographic recording included an electroencephalogram, an electrooculogram, an electromyogram, and an 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, week 12
Change from baseline anxiety to 12 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, week 12
Change from baseline mood to 12 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: 12 weeks
Change from baseline sleep quality to 12 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, 12 weeks
Change from baseline quality of life to 12 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 12
Change from baseline insomnia 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 12
Change from baseline sleep diary to 12 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 1 week. 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 [9]). These data were averaged for each volunteer for pre- and post-treatment assessment weeks.
Measured: baseline, week 12
Secondary outcomes (3)
Change from baseline serum serotonin to 12 weeks
The blood sample will be collected at 8a.m. The serum serotonin dosage will be made by high performance liquid chromatography (HPLC)
Measured: baseline, 12 weeks
Change from baseline cortisol to 12 weeks
The blood sample will be collected at 8a.m. The cortisol dosage will be made by chemiluminescence.
Measured: baseline, 12 weeks
Change from baseline Effort eletrocardiogram test to 12 weeks
The test will be performed on a treadmill according to the protocol of Bruce.
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start25 Sep 2017
- Primary completion30 Nov 2018
- Study completion15 May 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 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
- NCT03171519
- Sponsor's protocol ID
- 1.998.334
- Status last verified
- Feb 2021
- First submitted
- 18 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
- Effects of Exercise and Acupuncture on Chronic Insomnia: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03171519
- Acronym / sponsor ID
- 1.998.334
- Conditions
- Chronic Insomnia
- Keywords
- Physical activity, Disorders of onset and maintenance of sleep, non-pharmacological treatment, Acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidade Federal de GoiasUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 31 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: Chronic insomnia is a sleep disorder, characterized by difficulty in initiating and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at least 3 months. Pharmacologic therapy is the most commonly method used for its treatment, however, pharmacotherapy is associated with side effects. Thus, non-pharmacological therapies have been suggested as an alternative. Objective: To verify the effects of exercise associated with acupuncture on chronic insomnia. METHODS: 40 patients with chronic insomnia will be randomly assigned into two groups: CONTROL (n = 20) and ACUPUNCTURE (n = 20). The volunteers of the CONTROL group will be submitted to 12 weeks of aerobic exercise, performed on a treadmill, with frequency of 3 times / week and duration of 50 minutes / day. ACUPUNCTURE volunteers will perform aerobic exercise, following the protocol of the CONTROL group, plus acupuncture therapy once a week. The sleep evaluation will be evaluated by polysomnography and questionnaires. Expected Results: A 12-week combined therapy could potentiate the previously described positive effects of exercise in the treatment of chronic insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Active comparator | Behavioral: Exercise |
| Exercise + acupuncture | Experimental | Behavioral: Exercise, Behavioral: Acupuncture |
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 (performed by a physician specialized in Sleep Medicine);
- 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 os 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 |
|---|---|---|
| ExerciseThe EXERCISE group will participate in an aerobic exercise program for 12 weeks, performed in intensity relative to 50% of reserve heart rate, on a treadmill. | Behavioural | Exercise, Exercise + acupuncture |
| AcupunctureThe ACUPUNCTURE group will participate in an aerobic exercise program following the protocol of the EXERCISE group, plus acupuncture therapy once a week. | Behavioural | Exercise + acupuncture |
Primary outcome
Change from baseline polysomnography to 12 weeks
Time frame: baseline, week 12
Polysomnographic recording included an electroencephalogram, an electrooculogram, an electromyogram, and an 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
Change from baseline anxiety to 12 weeks
Time frame: baseline, week 12
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.
Change from baseline mood to 12 weeks
Time frame: 12 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
Change from baseline sleep quality to 12 weeks
Time frame: baseline, 12 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.
Change from baseline quality of life to 12 weeks
Time frame: baseline, week 12
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
Change from baseline insomnia to 12 weeks
Time frame: baseline, week 12
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
Change from baseline sleep diary to 12 weeks
Time frame: baseline, week 12
The sleep diary was used to evaluate the subjective perceptions of sleep. Participants were instructed to complete the diary every morning after waking for 1 week. 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 [9]). These data were averaged for each volunteer for pre- and post-treatment assessment weeks.
3 secondary outcomes
Change from baseline serum serotonin to 12 weeks
Time frame: baseline, 12 weeks
Change from baseline cortisol to 12 weeks
Time frame: baseline, 12 weeks
Change from baseline Effort eletrocardiogram test to 12 weeks
Time frame: baseline, 12 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 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 study testing Exercise and Acupuncture 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.
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 polysomnography to 12 weeks (time frame: baseline, week 12). The study lists 7 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 1 Mar 2021.