Lifestyle Intervention for OSA in Adults

University of Granada (UGR)

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Lifestyle Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03851653

INTERAPNEA-2019

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous clinical diagnosis of moderate/severe OSA (AHI > 15) by a healthcare professional.
• Male patients aged between 18-65 years.
• Body mass index > 25 kg/m2.
• Use of CPAP
• Motivation to participate in the study.
• Signed informed consent form.

Exclusion criteria

• Sleep disorder other than OSA
• Clinically significant psychiatric, neurological, or medical disorders other than OSA
• Use of prescription drugs or clinically significant drugs affecting sleep

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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89 participants in 2 patient groups

Lifestyle Intervention Group (LIG)

Experimental group

Description:

Participants from this group will receive a cognitive-behavioral intervention addressing weight loss and lifestyle habits such as hypocaloric diet, moderate exercise, smoking and alcohol avoidance, and sleep hygiene. This behavioral intervention will be combined with the usual treatment for OSA, i.e. CPAP.

Treatment:

Behavioral: Lifestyle Intervention

Control group

No Intervention group

Description:

Participants from the control group will not receive any type of intervention apart from the usual care (CPAP).