Zolpidem or Exercise for Insomnia?

NCT ID: NCT03160404

Last Updated: 2021-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2020-02-15

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.

Conditions

Chronic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EXERCISE

Aerobic exercise (50% Reserve heart hate), 50 minutes, 3 times/week, during 6 weeks.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

The EXERCISE group will participate in an aerobic exercise program, performed in intensity relative to 50% of reserve heart rate, on a treadmill.

ZOLPIDEM

10 mg/night during 6 weeks

Group Type: ACTIVE_COMPARATOR

Zolpidem

Intervention Type: DRUG

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

Interventions

Zolpidem

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

Intervention Type: DRUG

Exercise

The EXERCISE group will participate in an aerobic exercise program, performed in intensity relative to 50% of reserve heart rate, on a treadmill.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Federal de Goias

OTHER

Sponsor Role: lead

Responsible Party

Giselle Soares Passos

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Padre Thiago

Jatai, Goiás, Brazil

Countries

Brazil

Other Identifiers

1.986.600

Identifier Type: -

Identifier Source: org_study_id