Lifestyle Intervention for Obstructive Sleep Apnea in Women (INTERAPNEA-W)

University of Granada (UGR)

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Weight loss and lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06370806

INTERAPNEA-Women

Details and patient eligibility

About

Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous clinical diagnosis of moderate/severe OSA (AHI > 15)
• Female 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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180 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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

Lifestyle Intervention

Experimental group

Description:

Participants from this group will receive a interdisciplinary intervention addressing weight loss and lifestyle change including nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care (i.e., CPAP)

Treatment:

Behavioral: Weight loss and lifestyle intervention