Lifestyle Intervention for Obstructive Sleep Apnea in Women

NCT ID: NCT06370806

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Lifestyle Intervention

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)

Group Type: EXPERIMENTAL

Weight loss and lifestyle intervention

Intervention Type: BEHAVIORAL

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)

Interventions

Weight loss and lifestyle intervention

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundación BBVA

UNKNOWN

Sponsor Role: collaborator

Universidad Loyola Andalucia

OTHER

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Almudena Carneiro Barrera

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Almudena Carneiro-Barrera, PhD

Role: CONTACT

acarneiro@uloyola.es

656556547

Other Identifiers

INTERAPNEA-Women

Identifier Type: -

Identifier Source: org_study_id