Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study

October 9, 2017 updated by: Solent NHS Trust

A Feasibility Study Monitoring the Respiratory Status of Participants Receiving or Scheduled to Receive Intrathecal Baclofen (ITB)

The methodology is a feasibility study to determine the feasibility of assessing people in the community with a neurological condition before proceeding towards a full powered community trial evaluating the influence of intrathecal baclofen.

Study Overview

Status

Completed

Conditions

Detailed Description

The purpose of this proposed research will evaluate a feasible method to assess the respiratory status of people with neurological conditions receiving or scheduled to receive Intrathecal Baclofen. The use of Intrathecal Baclofen to manage severe spasticity is a developing treatment option with a limited research base, particularly when evaluating the influence of intrathecal baclofen on the respiratory system. The proposed research is derived from clinical practice and involves joint collaboration between clinical team, research professionals and patients.

In order for the study to evaluate the influence of Intrathecal baclofen has on the respiratory system, the proposed research will need to develop and evaluate a method of assessing people in the community ensuring it's feasible for people with neurological conditions. Prior to implementing a full powered community trial to evaluate the influence of intrathecal baclofen on people with neurological conditions.

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom
        • Solent NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with Neurological conditions receiving or scheduled to receive intrathecal baclofen therapy.

Description

Inclusion Criteria:

  • -Adults over the age of 18
  • A person who is able to provide consent or a family member/ close friend who is able to assent on behalf of the participant
  • A person or a family member/ close friend who is able to understand English (understand written English and spoken instructions)
  • A person currently receiving Intrathecal Baclofen or is scheduled to receive Intrathecal Baclofen (awaiting fitting of pump) therapy to manage spasticity
  • A patient of the Solent/ University Hospitals Southampton NHS Foundation Trust Intrathecal baclofen service

Exclusion Criteria:

  • -Pre-existing use of overnight non-invasive ventilation (NIV) and is compliant with NIV treatment
  • A person who is unable to consent to the study and does not have a family/ close person to assent
  • The study will exclude a person who is unable to independently remove the polysomnography and is also without supervision from another person (carer or partner) during the night. This ensures the participant is able to take off the polysomnography (or assisted by a carer) if it becomes uncomfortable and/or causes distress.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overnight home polysomnography
Time Frame: 2 nights
sleep study
2 nights

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview
Time Frame: 2 nights
Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview
2 nights

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solent NHS Trust

Investigators

  • Principal Investigator: Hayden Kirk, Solent NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2017

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

March 13, 2017

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 10, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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