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Zolpidem or Exercise for Insomnia?

NCT03160404 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-03-01

No results posted yet for this study

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.

Conditions

  • Chronic Insomnia

Interventions

DRUG

Zolpidem

The ZOLPIDEM group will be treated with zolpidem 10mg/night

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.

Sponsors & Collaborators

  • Universidade Federal de Goias

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2019-12-30
Completion
2020-02-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03160404 on ClinicalTrials.gov