NCT01314651

Brief Summary

The purpose of this study is to test the efficacy of a brief behavioral insomnia intervention in reducing headache frequency and severity among patients with chronic migraine and insomnia. It is hypothesized that this intervention will produce greater changes in headache frequency and severity than will a comparison treatment involving non-sleep-specific general lifestyle modifications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

2.8 years

First QC Date

March 11, 2011

Last Update Submit

April 22, 2014

Conditions

Chronic MigraineInsomnia

Keywords

Migraine DisordersChronic migraineInsomniaBehavioral sleep management

Outcome Measures

Primary Outcomes (1)

  • Headache frequency

    2 weeks post-treatment, 6 weeks post-treatment

Secondary Outcomes (3)

  • Headache severity

    2 weeks post-treatment, 6 weeks post-treatment

  • Headache-related disability

    2 weeks post-treatment; 6 weeks post-treatment

  • Total Sleep Time

    2 weeks post-treatment; 6 weeks post-treatment

Study Arms (2)

Sleep Management

EXPERIMENTAL

Instructions in stimulus control and sleep restriction.

Behavioral: Stimulus Control and Sleep Restriction

Lifestyle Modification

SHAM COMPARATOR

Instructions to change general lifestyle habits (maintain consistent liquid consumption, range of motion exercises, etc.)

Behavioral: Lifestyle Modification

Interventions

Stimulus Control and Sleep RestrictionBEHAVIORAL

5 instructions in stimulus control and individually-tailored sleep restriction

Sleep Management
Lifestyle ModificationBEHAVIORAL

5 instructions in changing general lifestyle habits (maintaining consistent liquid intake, range of motion exercises, eating a serving of protein in the morning, etc.)

Lifestyle Modification

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18-65 diagnosed with chronic migraine (15 or more days with headache per month, most of which must be migraine) and insomnia who present for routine medical care for migraine.

You may not qualify if:

  • Currently pregnant or breastfeeding, being unable to read or speak English at a 6th grade level, alcohol or substance abuse or dependence, bipolar disorder or seizure disorder, psychiatric hospitalization within the last year, medication overuse headache, and patients not stable on current migraine medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychological Services Center

University, Mississippi, 38677, United States

Location

Related Publications (1)

  • Smitherman TA, Walters AB, Davis RE, Ambrose CE, Roland M, Houle TT, Rains JC. Randomized Controlled Pilot Trial of Behavioral Insomnia Treatment for Chronic Migraine With Comorbid Insomnia. Headache. 2016 Feb;56(2):276-91. doi: 10.1111/head.12760. Epub 2016 Jan 27.

    PMID: 26813845DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersMigraine Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Todd A Smitherman, Ph.D.

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
University of Mississippi Clinical Trials and FDA Administrator

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 14, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

US(1)