What is the mechanism of action of this treatment?

Common treatments for sleep disorders, such as mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy for insomnia (CBT-I), work by addressing psychological and behavioral factors that affect sleep. MBSR reduces stress and improves mental well-being through mindfulness practices, helping patients manage anxiety and promote relaxation. CBT-I focuses on changing negative thoughts and behaviors related to sleep, improving sleep hygiene, and establishing a regular sleep schedule. These nonpharmacologic treatments are crucial for sleep disorder patients as they offer sustainable solutions that address the root causes of sleep disturbances, leading to long-term improvements in sleep quality and overall health.

What side effects are associated with this type of intervention?

Mindfulness-based interventions, such as mindfulness meditation and mindfulness-based stress reduction (MBSR), are generally considered safe with minimal side effects. Some individuals may experience temporary discomfort, such as increased awareness of stress or anxiety, but these effects typically diminish with continued practice. Cognitive behavioral therapy for insomnia (CBT-I) is also well-tolerated, though it may initially cause increased anxiety or frustration as patients adjust to new sleep habits. Pharmacological treatments, including benzodiazepines and non-benzodiazepine hypnotics, can cause side effects such as daytime drowsiness, dizziness, dependency, and withdrawal symptoms. It is important to discuss these options with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of sleep disorders, including zolpidem (Ambien), eszopiclone (Lunesta), and ramelteon (Rozerem), which are primarily used to treat insomnia. These medications work by targeting different pathways in the brain to promote sleep. In addition to pharmacological treatments, cognitive-behavioral therapy for insomnia (CBT-I) is a widely recognized non-pharmacological approach that has been shown to improve sleep quality by addressing the underlying cognitive and behavioral factors contributing to insomnia. While mindfulness meditation itself is not FDA-approved, it is a complementary practice that can reduce stress and improve mental well-being, potentially enhancing sleep quality when used alongside these approved treatments.

What other types of research exist?

Promising novel alternatives to Mindfulness Meditation for sleep disorder patients include: 1) Acupressure: Self-administered acupressure has shown effectiveness in improving sleep quality and reducing fatigue. 2) Cognitive Behavioral Therapy for Insomnia (CBT-I): This structured program helps patients change thoughts and behaviors that cause or worsen sleep problems. 3) Guided Imagery: This relaxation technique involves visualizing calming images and scenarios to promote better sleep. 4) Progressive Muscle Relaxation: This method involves tensing and then relaxing different muscle groups to reduce physical tension and improve sleep. 5) Hypnotherapy: This involves guided hypnosis to help patients enter a state of deep relaxation, which can improve sleep quality.

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Mindfulness Meditation for Sleep Disorders

N/A

Recruiting

Led By Jason M Jennings, MD, DPT

Research Sponsored by Colorado Joint Replacement

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing primary unilateral total joint arthroplasty at Colorado Joint Replacement

Between the ages of 18 and 90 years old will be included in the study.

Must not have

Simultaneous total joint arthroplasty

Revision surgery for infection, fracture or other indication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-op to 2, 6 and 12 weeks post op.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a short mindfulness meditation session before joint replacement surgery can improve sleep quality. The goal is to see if this simple practice helps patients sleep better after their surgery by reducing stress and enhancing well-being.

Who is the study for?

This trial is for individuals aged 18-90 who are scheduled for a primary unilateral total joint arthroplasty at Colorado Joint Replacement. It's not open to those having simultaneous joint replacements, unable to attend pre-op appointments within 4 weeks of surgery, with a history of substance abuse, or needing revision surgeries.

What is being tested?

The study tests if a 15-minute Mindfulness Meditation (MM) session before surgery can improve sleep quality post-surgery. Sleep quality is measured using the Pittsburg Sleep Quality Index (PSQI) at different intervals after the operation.

What are the potential side effects?

Mindfulness Meditation is generally considered safe and side effects are rare. However, some individuals may experience temporary discomfort like restlessness or emotional distress during meditation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a joint replacement surgery at Colorado Joint Replacement.

Select...

I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am having or have had joint replacement surgery on more than one joint at the same time.

Select...

I need surgery again due to infection, fracture, or another reason.

Select...

I can attend a pre-op appointment within 4 weeks before my surgery.

Select...

I have had a partial knee replacement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-op to 2, 6 and 12 weeks post op.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre-op to 2, 6 and 12 weeks post op.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-op to 2, 6 and 12 weeks post op. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pittsburg Sleep Quality Index score

Secondary study objectives

Epworth Sleepiness Scale

Knee Injury and Osteoarthritis Outcome Scores JR

Knee Society Score (KSS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Multiple Mindfulness MeditationExperimental Treatment1 Intervention

Mindfulness Video Training at Pre-Op, 1 Day Prior to surgery, 3 day's Post OP and 2 Weeks Post OP.

Group II: Mindfulness at Pre-OpExperimental Treatment1 Intervention

Patient will receive a one time training at their pre-operative appointment.

Group III: No TreatmentActive Control1 Intervention

Patient will receive no mindfulness meditation training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness Meditation Training

2019

N/A

~250

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sleep disorders, such as mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy for insomnia (CBT-I), work by addressing psychological and behavioral factors that affect sleep. MBSR reduces stress and improves mental well-being through mindfulness practices, helping patients manage anxiety and promote relaxation. CBT-I focuses on changing negative thoughts and behaviors related to sleep, improving sleep hygiene, and establishing a regular sleep schedule. These nonpharmacologic treatments are crucial for sleep disorder patients as they offer sustainable solutions that address the root causes of sleep disturbances, leading to long-term improvements in sleep quality and overall health.

Insomnia disorder: State of the science and challenges for the future.A randomized controlled trial of mindfulness-based stress reduction for insomnia secondary to cervical cancer: Sleep effects.