Zolpidem or Exercise for Insomnia?

NCT03160404 | Completed Early Phase 1 DMC

• 1 other identifier: 1.986.600
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Zolpidem; Sleep

Outcome Measures

Primary Outcomes (1)

• Change from baseline polysomographic sleep recording to first night and 6 weeks

  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

  baseline, first night, week 6

Secondary Outcomes (10)

• Change from baseline actigraphy sleep recording to first night and 6 weeks

  baseline, first night, week 6

• Change from baseline sleep diary recording to first night and 6 weeks

  baseline, first night, week 6

• Change from baseline prior sleep anxiety to first night and 6 weeks

  baseline, first night, week 6

• Change from baseline insomnia severity to 12 weeks

  baseline, week 6

• Change from baseline sleep quality to 6 weeks

  baseline, week 6

Study Arms (2)

EXERCISE

EXPERIMENTAL

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

Behavioral: Exercise

ZOLPIDEM

ACTIVE COMPARATOR

10 mg/night during 6 weeks

Drug: Zolpidem

Interventions

Zolpidem DRUG

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

ZOLPIDEM

Exercise BEHAVIORAL

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

EXERCISE

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Goias: lead

Study Sites (1)

Hospital Padre Thiago

Jatai, Goiás, 75803495, Brazil

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Motor Activity

Interventions

Zolpidem; Exercise

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 19, 2017
• Study Start: April 16, 2018
• Primary Completion: December 30, 2019
• Study Completion: February 15, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

BR (1)