Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study

NCT03151941 | Completed

• 1 other identifier: 1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrathecal Baclofen; Multiple Sclerosis; Respiratory System; Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Overnight home polysomnography

  sleep study

  2 nights

Secondary Outcomes (1)

• Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview

  2 nights

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Solent NHS Trust: lead

Study Sites (1)

Solent NHS Trust

Portsmouth, Hampshire, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cerebral Palsy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Hayden Kirk

  Solent NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: May 12, 2017
• Study Start: March 6, 2017
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: October 10, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)