Experimental group for Insomnia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
InsomniaMindfulness - Behavioral
Eligibility
20 - 50
All Sexes
What conditions do you have?
Select

Study Summary

This is a pilot study evaluating the feasibility and acceptability of a non-pharmacological, mind-body intervention to improve sleep quality, including a preliminary evaluation of neurophysiological signals. The study involves 4 weeks of guided mind-body practice at home using a smartphone app during bedtime and pre/post in-lab sleep study visits.

Eligible Conditions
  • Insomnia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: At one month follow up visit

At baseline and at the end of 4-week program
Insomnia Severity Index
Polysomnogram-derived sleep efficiency
Polysomnogram-derived sleep onset latency
Week 4
Acceptability
At one month follow up visit
Feasibility (i.e., subject retention at initial follow-up assessment)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control group
1 of 2
Experimental group
1 of 2

Active Control

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Experimental group · No Placebo Group · N/A

Experimental group
Behavioral
Experimental Group · 1 Intervention: Mindfulness · Intervention Types: Behavioral
Control groupNoIntervention Group · 1 Intervention: Control group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness
2014
Completed Phase 3
~2910

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at one month follow up visit

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
778 Previous Clinical Trials
844,421 Total Patients Enrolled
4 Trials studying Insomnia
262 Patients Enrolled for Insomnia

Eligibility Criteria

Age 20 - 50 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you: