Lifestyle Intervention for Obstructive Sleep Apnea in Women

NCT06370806 | Not Yet Recruiting DMC

• 1 other identifier: INTERAPNEA-Women
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Apnoea-hypopnoea index (AHI)

  Change in apnea (airflow reduction greater than or equal to 90%) and hypopnea (airflow reduction greater than or equal to 30%) episodes per hour of sleep measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)

  Post-intervention (2 months)

Secondary Outcomes (20)

• Oxygen desaturation index (ODI)

  Post-intervention (2 months)

• Oxygen saturation (SaO2) mean

  Post-intervention (2 months)

• Oxygen saturation (SaO2) nadir

  Post-intervention (2 months)

• Sleep efficiency

  Post-intervention (2 months)

• Light sleep (N1 and N2 stages)

  Post-intervention (2 months)

Study Arms (2)

Usual Care

NO INTERVENTION

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

Lifestyle Intervention

EXPERIMENTAL

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)

Behavioral: Weight loss and lifestyle intervention

Interventions

Weight loss and lifestyle intervention 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)

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• Fundación BBVA: collaborator
• Universidad Loyola Andalucia: collaborator

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Almudena Carneiro-Barrera, PhD

CONTACT

656556547; acarneiro@uloyola.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 17, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication of main findings
• Access Criteria: Accepted proposals by the INTERAPNEA-Women team