Clinical trial NCT03160404: Zolpidem or Exercise for Insomnia?
Official title: The Effects of Zolpidem Compared With Exercise on Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Insomnia
Keywords: Exercise
Zolpidem
Sleep
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline polysomographic sleep recording to first night and 6 weeks
timeFrame: baseline, first night, week 6
Secondary outcomes:
measure: Change from baseline actigraphy sleep recording to first night and 6 weeks
timeFrame: baseline, first night, week 6
measure: Change from baseline sleep diary recording to first night and 6 weeks
timeFrame: baseline, first night, week 6
measure: Change from baseline prior sleep anxiety to first night and 6 weeks
timeFrame: baseline, first night, week 6
measure: Change from baseline insomnia severity to 12 weeks
timeFrame: baseline, week 6
measure: Change from baseline sleep quality to 6 weeks
timeFrame: baseline, week 6
measure: Change from baseline mood to 6 weeks
timeFrame: baseline, week 6
measure: Change from baseline quality of life to 6 weeks
timeFrame: baseline, week 6
measure: Change from baseline serum serotonin to first night and 6 weeks
timeFrame: baseline, first night, week 6
measure: Change from baseline cortisol to first night and 6 weeks
timeFrame: baseline, first night, week 6
measure: Change from baseline Effort Exercise test to 6 weeks
timeFrame: baseline, week 6
Other outcomes:
Locations:
city: jATAÍ
country: Brazil
facility: Hospital Padre Thiago
state: GO
Study officials:
References: