Obstructive Sleep Apnea
Conditions
Keywords
obstructive sleep apnea
Brief summary
Continuous positive airway pressure (CPAP) is the gold-standard treatment for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing in the overall population. CPAP has shown to be effective in reducing apnoea-hypopnoea index (AHI) as well as other OSA polysomnographic outcomes. However, the effectiveness of this device on OSA daily functioning and mood disturbances outcomes still remains unclear. The ADIPOSA study is aimed at determining the effects of three-month CPAP use on anxiety-depression symptoms in patients with OSA. Participants will be adults previously diagnosed with OSA who will be allocated to a CPAP-treatment group. Outcomes will be measured at baseline and intervention end-point (three months) including daytime sleepiness, daily functioning and mood (anxiety and depression symptoms), AHI, other neurophysical and cardiorespiratory polysomnographic outcomes, and body weight. ADIPOSA may serve to establish the effectiveness of CPAP on daytime functioning and mood disturbances commonly found on patients with OSA and, in turn, on other OSA outcomes related to anxiety-depression symptoms.
Interventions
DEVICEContinuous positive airway pressure (CPAP)
Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention
Sponsors
University Hospital Virgen de las Nieves
Universidad de Granada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Uncontrolled before-and-after study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previous clinical diagnosis of mild/moderate/severe OSA (AHI \> 5) by a healthcare professional * Use of CPAP * Motivation to participate in the study * Willing to provide informed consent
Exclusion criteria
* Presence of any other primary sleep disorder * Presence of any mental disorder (including depression, anxiety, and addiction to alcohol or other substances) * Presence of any other severe organic disease, except for those comorbid to OSA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety symptoms measured by State-Trait Anxiety Inventory (STAI) | Three months | Changes in state anxiety and trait anxiety components measured by STAI questionnaire after three-month CPAP usage |
| Change in depression symptoms measured by Beck's Depression Inventory-Fast Screen (BDI-FS) | Three months | Changes in depression symptoms measured by BDI-FS questionnaire after three-month CPAP usage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention | Three months | Change in apnoea (airflow reduction greater than or equal to 90%) and hypopnoea (airflow reduction greater than or equal to 30%) episodes per hour of sleep, from baseline to post-intervention. |
| Change in oxygen desaturation index (ODI) from baseline to post-intervention. | Three months | Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention. |
| Change in excessive daytime sleepiness (EDS) from baseline to post-intervention | Three months | Change in the difficulty in maintaining a desired level of wakefulness, measured by the Epworth sleepiness scale (ESS) from baseline to post-intervention. ESS is a 4-point scale (0 = no chance of dozing, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing) that measures the usual chances of dozing off or falling asleep while engaged in eight different activities. An ESS total score from 0 to 9 is considered to be normal while an ESS total score \> 9 indicates high daytime sleepiness. |
| Change in body mass index (BMI) | Three months | Change in body mass index from baseline to post-intervention |
Countries
Spain
Outcome results
None listed