NCT03851653

Lifestyle Intervention for OSA in Adults

Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI \> 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. OSA has an important negative impact on physical/psychological health and on these patient's quality of life. The gold-standard treatment for OSA is the continuous positive airway pressure (CPAP). However, CPAP compliance is really low, this device requiring a continuous chronic use in order to improve OSA and to avoid the relapse. Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the American Academy of Sleep Medicine (AASM). The objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in comparison with CPAP, in a short and medium term. This intervention could be considered a good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in the long-term.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle Intervention	Cognitive-behavioural intervention for weight loss and lifestyle change

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-10-13
• Completion: 2020-11-30
• First posted: 2019-02-22
• Last updated: 2021-01-12

Locations

1 site across 1 country: Spain