Improvement of pain and quality of life in patients with sickle cell disease with overnight oxygen therapy or auto-adjusting positive airway pressure (APAP)

Conditions

Sickle Cell Disease Haematological Disorders Sickle-cell anaemia without crisis

Howard J, Lee SA, Inusa B, Cheng MYE, Bavenjit C, Reading IC, Wakeford SA, Gavlak JC, Murphy PB, Hart N, Gupta A, Sahota S, Jacob E, Chorozoglou M, Ossai C, Gwam M, Kirkham FJ, Wade AM, Liossi C.

2019-07-184 citations

10.1186/s13063-019-3461-x

Prevention of Morbidity in sickle cell disease--qualitative outcomes, pain and quality of life in a randomised cross-over pilot trial of overnight supplementary oxygen and auto-adjusting continuous positive airways pressure (POMS2a): study protocol for a randomised controlled trial.

Howard J, Inusa B, Liossi C, Jacob E, Murphy PB, Hart N, Gavlak J, Sahota S, Chorozoglou M, Nwosu C, Gwam M, Gupta A, Rees DC, Thein SL, Reading IC, Kirkham FJ, Cheng MY.

2015-08-256 citations

10.1186/s13063-015-0883-y

Interventions

Participants will have two interventions, APAP and overnight oxygen, for a week each in randomized order (week 2 and 4). There will be a week of baseline data collection (week 1), and a week of washou

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age over 8 years 2. Informed consent with assent in accordance with the institutional policies (UK ethical committee) and European or US Federal guidelines 3. Sickle cell haemoglobin (HbSS) diagnosed by standard techniques 4. Able to speak and understand English 5. Patient or parent/guardian able to use smart phone

Exclusion criteria

Exclusion criteria: 1. Patient already on overnight respiratory support or has used it in the past 2. Hospital admission for acute sickle complication within the past 1 month 3. Patient with > 6 admissions for acute sickle complications within the past 12 months 4. Existing Respiratory Failure 5. Decompensated Cardiac Failure 6. History of Severe Epistaxis 7. Transsphenoidal

Design outcomes

Primary

Measure	Time frame
Patient feasibility, acceptability and preference will be explored using qualitative interviews	—

Secondary

Measure	Time frame
1. Pain: Using available Smartphone technology, information on: 1.1. Pain characteristics (intensity, location, quality) 1.2. Pain medications and non-pharmacological strategies used for pain 1.3. Healthcare visits will be collected in the pilot to test out the methodology and to determine whether there is any obvious effect of either intervention or its withdrawal, particularly if detrimental. This is important as the first outcome measure for trial 2b will be average pain intensity during the two observation periods. 2. Adverse events: The Clinical Report Forms (CRFs) for reporting adverse events will be trialed during this pilot to show efficacy in recording and reporting adverse events. 3. Daytime oxygen saturation will be collected before and after each intervention to determine whether there is any obvious effect of either intervention or its withdrawal, particularly if detrimental. 4. Lung volume will be collected before and after each intervention to determine whether there is any obvious effect of either intervention or its withdrawal, particularly if detrimental.	—

Measure

Time frame

1. Pain: Using available Smartphone technology, information on: 1.1. Pain characteristics (intensity, location, quality) 1.2. Pain medications and non-pharmacological strategies used for pain 1.3. Healthcare visits will be collected in the pilot to test out the methodology and to determine whether there is any obvious effect of either intervention or its withdrawal, particularly if detrimental. This is important as the first outcome measure for trial 2b will be average pain intensity during the two observation periods. 2. Adverse events: The Clinical Report Forms (CRFs) for reporting adverse events will be trialed during this pilot to show efficacy in recording and reporting adverse events. 3. Daytime oxygen saturation will be collected before and after each intervention to determine whether there is any obvious effect of either intervention or its withdrawal, particularly if detrimental. 4. Lung volume will be collected before and after each intervention to determine whether there is any obvious effect of either intervention or its withdrawal, particularly if detrimental.

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Countries

United Kingdom

Outcome results

None listed