Neurocognitive function, sleep and well-being in patients with Cystic Fibrosis with mild lung disease

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616000454471

Acronym

Enrollment

Registered

2016-04-07

Start date

2016-04-18

Completion date

2016-08-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This will be an observational study in CF patients with mild lung disease, examining the relationship between neurocognitive function and sleep parameters. Additional factors to be studied include hypoxemia, inflammatory markers, circadian rhythm and mood. CF participants will be tested at baseline, during and after lung exacerbation. Age and education matched non-CF controls will be invited to participate as well. Summary of tests to be performed at each visit: 1. Sleep study with high density EEG 2. Blood tests 3. Activity and oxygen monitoring with watches 4. Neurocognitive tests and Questionnaires.

Interventions

Patients (CF and non-CF Controls) will be asked to complete the following at baseline, during and after an respiratory exacerbation/worsening. 1. CF and Sleep related questionnaires (Duration: 1/2 hour) 2. Oxygen (Duration: 3 nights) and Activity home monitoring (Duration: 7 days) watches 3. Sleep study (Duration: 1 night) 4. Neurocognitive testing battery on a computer (Duration: 2 hours) 5. Blood tests (part of routine care) Testing during and after an exacerbation applies to CF patients. Post exacerbation testing will be performed 4 weeks post recovery. Non CF controls will be invited to perform testing during a baseline visit and in the same time frame of an exacerbation for the matched CF participant (within 4-6 weeks). Patients will be monitored for their first exacerbation over the 21 month trial duration period.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

CF Inclusion criteria * FEV1 70 - 89% * Stable lung function (see exclusion criteria) Non CF healthy controls inclusion criteria * Matched for age and education to CF participant

Exclusion criteria

CF Patient Exclusion criteria * Uncontrolled medical conditions * Prescribed intravenous or oral antibiotics for CF exacerbation in the past 8 weeks * Patients with Burkholderia cepacia and non tuberculous mycobacteria * Prior lung transplant * Not proficient in English * Inability to provide informed consent Non-CF control exclusion criteria: * Uncontrolled medical conditions * Acute medical conditions - eg. active lung infection * Not proficient in English

Outcome results