Osteoarthritis of the KneeNCT01683799
Sleep, Pain and Inflammatory Processes in Older Adults With Osteoarthritis
A study testing Cognitive Behavioral Therapy for Insomnia in people with Osteoarthritis of the Knee and Insomnia, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee, Insomnia, Knee Pain
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-75 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
Who cannot join
- 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
Show all 9Show fewer
- active substance dependence
- untreated hypertension
- use of antidepressants (stable use for 3 months okay), antipsychotics, mood stabilizers, sedative-hypnotics, opiate analgesics
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Slow Wave Sleep and Inflammatory Processes in Pain
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.
- Conditions
- Osteoarthritis of the Knee, Insomnia, Knee Pain
- Being tested
- Cognitive Behavioral Therapy for Insomnia
- Keywords
- Osteoarthritis, Insomnia, Chronic pain, Cognitive Behavioral Therapy for Insomnia, Inflammation, Inflammatory cytokines
- Medical subject headings
- Osteoarthritis, Knee, Sleep Initiation and Maintenance Disorders, Osteoarthritis, Chronic Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
6-week behavioral treatment for insomnia
| Study group | Role | What they receive |
|---|---|---|
| Insomnia treatment | Experimental | Cognitive Behavioral Therapy for Insomnia Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in minutes of time in slow wave sleep
Measured: baseline and 10 weeks
Change from baseline in relative power of delta EEG activity to index slow wave sleep activity
Measured: baseline and 10 weeks
Change from baseline in nociception flexion reflex threshold
Measured: baseline and 10 weeks
Change from baseline in electrocutaneous pain threshold
Measured: baseline and 10 weeks
Change from baseline in inflammatory cytokine responses to pain
Measured: baseline and 10 weeks
Change from baseline in Western Ontario and McMaster University OA Index
Measured: baseline and 10 weeks
Change from baseline in Knee Pain Scale score
Measured: baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startFeb 2013
- Primary completionJul 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kathi Heffner, University of Rochester
- Investigators
- Kathi L. Heffner, PhD, Principal investigator, University of RochesterWilfred Pigeon, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683799
- Sponsor's protocol ID
- RSRB00044088
- Other IDs
- R21AG041942-01A1
- Status last verified
- Sep 2016
- First submitted
- 7 Sep 2012
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slow Wave Sleep and Inflammatory Processes in Pain
- ClinicalTrials.gov ID
- NCT01683799
- Acronym / sponsor ID
- RSRB00044088
- Conditions
- Osteoarthritis of the Knee, Insomnia, Knee Pain
- Keywords
- Osteoarthritis, Insomnia, Chronic pain, Cognitive Behavioral Therapy for Insomnia, Inflammation, Inflammatory cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Feb 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insomnia treatment | Experimental | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50-75 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia6-week behavioral treatment for insomnia | Behavioural | Insomnia treatment |
Primary outcome
Change from baseline in minutes of time in slow wave sleep
Time frame: baseline and 10 weeks
Change from baseline in relative power of delta EEG activity to index slow wave sleep activity
Time frame: baseline and 10 weeks
Change from baseline in nociception flexion reflex threshold
Time frame: baseline and 10 weeks
Change from baseline in electrocutaneous pain threshold
Time frame: baseline and 10 weeks
Change from baseline in inflammatory cytokine responses to pain
Time frame: baseline and 10 weeks
Change from baseline in Western Ontario and McMaster University OA Index
Time frame: baseline and 10 weeks
Change from baseline in Knee Pain Scale score
Time frame: baseline and 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathi L. Heffner, PhD principal investigator
University of Rochester
Wilfred Pigeon, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia in people with Osteoarthritis of the Knee and Insomnia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in minutes of time in slow wave sleep (time frame: baseline and 10 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.