NCT01683799

Brief Summary

The purpose if the study is to determine whether improving sleep, especially slow wave or "deep" sleep, in older adults with osteoarthritis (OA) and insomnia reduces pain sensitivity and inflammatory responses to pain, and improves OA-related pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 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

First Submitted

Initial submission to the registry

September 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

September 7, 2012

Last Update Submit

September 28, 2016

Conditions

Osteoarthritis of the KneeInsomniaKnee Pain

Keywords

OsteoarthritisInsomniaChronic painCognitive Behavioral Therapy for InsomniaInflammationInflammatory cytokines

Outcome Measures

Primary Outcomes (7)

  • Change from baseline in minutes of time in slow wave sleep

    baseline and 10 weeks

  • Change from baseline in relative power of delta EEG activity to index slow wave sleep activity

    baseline and 10 weeks

  • Change from baseline in nociception flexion reflex threshold

    baseline and 10 weeks

  • Change from baseline in electrocutaneous pain threshold

    baseline and 10 weeks

  • Change from baseline in inflammatory cytokine responses to pain

    baseline and 10 weeks

  • Change from baseline in Western Ontario and McMaster University OA Index

    baseline and 10 weeks

  • Change from baseline in Knee Pain Scale score

    baseline and 10 weeks

Study Arms (2)

Insomnia treatment

EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Behavioral: Cognitive Behavioral Therapy for Insomnia

Control

NO INTERVENTION

Interventions

Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

6-week behavioral treatment for insomnia

Insomnia treatment

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age (for women, post-menopausal)
  • Kellgren-Lawrence grade II radiographic evidence of OA affecting one or both knees
  • knee pain on most days for ≥ 6 months
  • self-reported disability due to knee pain for ≥ 2 of the following: walking, kneeling, ascending or descending stairs, or performing daily activities
  • willing and able to avoid all prescription and non-prescription, non-opiate pain medication for 48 hours prior to testing and all narcotic pain medication for 2 weeks prior to testing
  • meets research diagnostic criteria for sleep maintenance insomnia

You may not qualify if:

  • health conditions with immunological components or undergoing or taking immunosuppressive therapies
  • conditions contraindicated for or potentially limiting ability to conduct NFR and/or cold pressor test (e.g. Raynaud's syndrome; seizures; prior MI; respiratory conditions; leg/hip nerve damage; BMI ≥ 32)
  • sleep disorders other than insomnia
  • dementia or cognitive impairment
  • history of schizophrenia or bipolar I disorder; current or recent history (within 3 months) of major psychiatric disorders
  • current depressive symptomatology or current suicidality
  • active substance dependence
  • untreated hypertension
  • use of antidepressants (stable use for 3 months okay), antipsychotics, mood stabilizers, sedative-hypnotics, opiate analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeSleep Initiation and Maintenance DisordersOsteoarthritisChronic PainInflammation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kathi L. Heffner, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

  • Wilfred Pigeon, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 12, 2012

Study Start

February 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

US(1)