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Zolpidem or Exercise for Insomnia?

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ClinicalTrials.gov Identifier: NCT03160404
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Giselle Soares Passos, Universidade Federal de Goias

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Chronic Insomnia Drug: Zolpidem Behavioral: Exercise Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Zolpidem Compared With Exercise on Chronic Insomnia
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EXERCISE
Aerobic exercise (50% Reserve heart hate), 50 minutes, 3 times/week, during 6 weeks.
Behavioral: Exercise
The EXERCISE group will participate in an aerobic exercise program, performed in intensity relative to 50% of reserve heart rate, on a treadmill.

Active Comparator: ZOLPIDEM
10 mg/night during 6 weeks
Drug: Zolpidem
The ZOLPIDEM group will be treated with zolpidem 10mg/night




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from baseline actigraphy sleep recording to first night and 6 weeks [ Time Frame: baseline, first night, week 6 ]
    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.

  2. Change from baseline sleep diary recording to first night and 6 weeks [ Time Frame: baseline, first night, week 6 ]
    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.

  3. Change from baseline prior sleep anxiety to first night and 6 weeks [ Time Frame: baseline, first night, week 6 ]
    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.

  4. Change from baseline insomnia severity to 12 weeks [ Time Frame: baseline, week 6 ]
    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.

  5. Change from baseline sleep quality to 6 weeks [ Time Frame: baseline, week 6 ]
    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.

  6. Change from baseline mood to 6 weeks [ Time Frame: baseline, week 6 ]
    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.

  7. Change from baseline quality of life to 6 weeks [ Time Frame: baseline, week 6 ]
    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

  8. Change from baseline serum serotonin to first night and 6 weeks [ Time Frame: baseline, first night, week 6 ]
    The serum serotonin dosage will be made by high performance liquid chromatography (HPLC). The blood sample will be collected at 8a.m.

  9. Change from baseline cortisol to first night and 6 weeks [ Time Frame: baseline, first night, week 6 ]
    The cortisol dosage will be made by competitive chemiluminescent immunoassay. The blood sample will be collected at 8a.m.

  10. Change from baseline Effort Exercise test to 6 weeks [ Time Frame: baseline, week 6 ]
    The test will be performed on a treadmill according to the protocol of Bruce.



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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).

Exclusion criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160404


Contacts
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Contact: GISELLE PASSOS, PHD 55 64 3606-8304 passos.gs@gmail.com

Locations
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Brazil
Hospital Padre Thiago Recruiting
jATAÍ, GO, Brazil, 75803495
Contact: Walkyria Ferreira, Ft    5564999214318      
Sponsors and Collaborators
Universidade Federal de Goias

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Responsible Party: Giselle Soares Passos, Professor, Universidade Federal de Goias
ClinicalTrials.gov Identifier: NCT03160404     History of Changes
Other Study ID Numbers: 1.986.600
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giselle Soares Passos, Universidade Federal de Goias:
Exercise
Zolpidem
Sleep

Additional relevant MeSH terms:
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Zolpidem
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action