Clinical trial NCT03151941: Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study
Official title: A Feasibility Study Monitoring the Respiratory Status of Participants Receiving or Scheduled to Receive Intrathecal Baclofen (ITB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrathecal Baclofen
Multiple Sclerosis
Respiratory System
Cerebral Palsy
Lead sponsor: Solent NHS Trust
Sponsor class: OTHER_GOV
First posted: 2017-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Neurological conditions receiving or scheduled to receive intrathecal baclofen therapy.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overnight home polysomnography
timeFrame: 2 nights
Secondary outcomes:
measure: Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview
timeFrame: 2 nights
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Solent NHS Trust
state: Hampshire
Study officials:
affiliation: Solent NHS Trust
name: Hayden Kirk
role: PRINCIPAL_INVESTIGATOR
References: