Clinical trial NCT06370806: Lifestyle Intervention for Obstructive Sleep Apnea in Women
Official title: Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnea in Women: The INTERAPNEA-Women Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Fundación BBVA
name: Universidad Loyola Andalucia
First posted: 2024-04-17
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Apnoea-hypopnoea index (AHI)
timeFrame: Post-intervention (2 months)
Secondary outcomes:
measure: Oxygen desaturation index (ODI)
timeFrame: Post-intervention (2 months)
measure: Oxygen saturation (SaO2) mean
timeFrame: Post-intervention (2 months)
measure: Oxygen saturation (SaO2) nadir
timeFrame: Post-intervention (2 months)
measure: Sleep efficiency
timeFrame: Post-intervention (2 months)
measure: Light sleep (N1 and N2 stages)
timeFrame: Post-intervention (2 months)
measure: Deep sleep (N3 stage)
timeFrame: Post-intervention (2 months)
measure: Rapid eye movement (REM) sleep
timeFrame: Post-intervention (2 months)
measure: Excessive daytime sleepiness (EDS)
timeFrame: Post-intervention (2 months)
measure: Sleep Quality
timeFrame: Post-intervention (2 months)
measure: Wake After Sleep Onset (WASO)
timeFrame: Post-intervention (2 months)
measure: Fat mass (kg)
timeFrame: Post-intervention (2 months)
measure: Visceral adipose tisue (g)
timeFrame: Post-intervention (2 months)
measure: Body weight (kg)
timeFrame: Post-intervention (2 months)
measure: Neck circumference (cm)
timeFrame: Post-intervention (2 months)
measure: Chest circumference (cm)
timeFrame: Post-intervention (2 months)
measure: Waist circumference (cm)
timeFrame: Post-intervention (2 months)
measure: Mean blood pressure (mm HG)
timeFrame: Post-intervention (2 months)
measure: Plasma glucose (mg/dL)
timeFrame: Post-intervention (2 months)
measure: Change in total cholesterol (mg/dL) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
measure: Change in total triglycerides (mg/dL) from baseline to post-intervention
timeFrame: Post-intervention (2 months)
Other outcomes:
Locations:
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