NCT00303342

Brief Summary

The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2006

Typical duration for phase_2

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, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

Enrollment Period

3.3 years

First QC Date

March 14, 2006

Last Update Submit

January 12, 2010

Conditions

Insomnia

Keywords

sleeparousalstresscortisolcatecholamines

Outcome Measures

Primary Outcomes (6)

  • plasma cortisol

    pretreatment, posttreatment

  • plasma melatonin

    pretreatment, posttreatment

  • urinary catecholamines

    pretreatment, posttreatment

  • heart rate variability

    pretreatment, posttreatment

  • subjective sleep efficiency

    pretreatment, during treatment, posttreatment, followup

  • objective sleep efficiency

    pretreatment, posttreatment

Secondary Outcomes (5)

  • actigraphy

    pretreatment, posttreatment

  • EEG

    pretreatment, posttreatment

  • subjective mood

    pretreatment, during treatment, posttreatment, followup

  • depression

    pretreatment, during treatment, posttreatment, followup

  • anxiety

    pretreatment, during treatment, posttreatment, followup

Study Arms (2)

mind body treatment

EXPERIMENTAL

regulation of attention, respiration and posture

Behavioral: mind body treatment

desensitization

ACTIVE COMPARATOR

mentation on insomnia behaviors and cognitive activity

Behavioral: desensitization

Interventions

mind body treatmentBEHAVIORAL

regulation of attention, respiration and posture

mind body treatment
desensitizationBEHAVIORAL

mentation on insomnia behaviors and cognitive activity

desensitization

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • primary insomnia for 6 months
  • average total wake time \>60 minutes and sleep efficiency \<80%
  • at least 1 daytime complaint due to insomnia
  • adequate opportunity and circumstance for sleep

You may not qualify if:

  • current psychiatric condition
  • medical condition that interferes with sleep
  • pregnancy
  • rotating shift work, night work or transcontinental travel during study
  • anticipated major life stressor over the course of the study
  • use of hypnotic or psychoactive medications
  • no idiopathic or sleep state misperception insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sleep Disorders Program, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Desensitization, Psychologic

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sat Bir S Khalsa, Ph.D.

    Brigham and Women's Hospital, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 16, 2006

Study Start

March 1, 2006

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations

US(1)