Zolpidem or Exercise for Insomnia?

Universidade Federal de Goias

Status and phase

Completed

Early Phase 1

Conditions

Chronic Insomnia

Treatments

Behavioral: Exercise

Drug: Zolpidem

Study type

Interventional

Funder types

Other

Identifiers

NCT03160404

1.986.600

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.