Excessive daytime sleepiness in people living with HIV Infections and Infestations Human immunodeficiency virus [HIV] disease
Conditions
Interventions
The study is in three parts with a total duration of 15 months:
Part 1: The trialists will be performing a questionnaire on 325 participants (a representative sample of the outpatient
Sponsors
Royal Free London NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1 (questionnaire study): 1. HIV positive patient attending outpatient appointment at Royal Free Hospital 2. Informed consent to participate in study 3. Aged >18 Part 2 (investigating participants with excessive daytime sleepiness): 1. As per part 1 plus Epworth Sleepiness Scale score >10 Part 3 (evaluating CPAP treatment in those found to have obstructive sleep apnoea): 1. As per Part 1 and 2 plus Positive sleep study for evidence of obstructive sleep apnoea with Apnoea Hypopnoea Index =15
Exclusion criteria
Exclusion criteria: Part 1: 1. Aged <18 2. Consent not given to participate in study 3. Unable to participate for the duration of the study Part 2: 1. As per above (Part 1) plus Epworth sleepiness score =10 2. Pregnancy 3. Socioeconomic factors such as no fixed abode making regular outpatient attendance and communication too challenging Part 3: As per Part 2 and 3 plus: 1. AHI <5 on sleep study 2. Physical disability such as previous stroke that renders the patient unable to use CPAP treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimated prevalence of obstructive sleep apnoea syndrome (OSAS, obstructive sleep apnoea with excessive daytime sleepiness) in the outpatient HIV population attending the Royal Free Hospital. This is a derived value obtained by a two-step analysis. 1. Using a representative sample of 325 patients, the number of participants with excessive daytime sleepiness as measured by an Epworth Sleepiness Scale score (ESS) >10 2. Using sleep study data on the participants with ESS >10, the number of participants with obstructive sleep apnoea (OSA), classified as AHI 5-15 (mild OSA), AHI 15-30 (moderate OSA) and ESS >30 (severe OSA). The total number of participants with proven OSA in the sleep study will be utilised as a percentage of the total number sampled to estimate a prevalence of OSAS in the outpatient HIV population | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The sample population scores on other symptom and behaviour based questionnaires (FSS, PSQI, GAD-7, PHQ-9, EuroQOL 5D 5L) and the correlation of these with reported sleepiness score on ESS 2. Adherence and hours of use of CPAP in HIV-positive patients with proven moderate to severe OSA 3. AHI on treatment as recorded by the CPAP machines and comparison to pre-treatment values 4. The change in symptom scores pre- and post- CPAP treatment (ESS, FSS, GAD-7, PHQ-9, EuroQOL 5D 5L) in HIV-positive participants with proven moderate to severe OSA | — |
Countries
United Kingdom
Contacts
Public ContactAmina Jaffer
Outcome results
None listed