Annamaria Giraldi

Sexual Function in Female Patients with Obstructive Sleep Apnea.

INTRODUCTIONnObstructive sleep apnea is defined as repetitive (≥5/hour) partial or complete cessation of breathing during sleep. Whereas obstructive sleep apnea is often considered to be associated with sexual problems in men, studies concerning effects of obstructive sleep apnea on female sexual function and distress are sparse.nnnAIMnTo investigate sexual dysfunction and sexual distress in female patients with obstructive sleep apnea and to determine which factors are of importance for their sexual function.nnnMETHODSnWe investigated 80 female patients (ages 28-64) admitted to a sleep laboratory and who after investigation received a diagnosis of obstructive sleep apnea. All subjects answered questions drawn from three self-administered questionnaires on sexuality. The results were compared with a population sample (N=240).nnnMAIN OUTCOME MEASUREnu2002 Data from nocturnal respiratory recordings. Female Sexual Function Index, Female Sexual Distress Scale and four questions from Life Satisfaction-11 (Lisat-11).nnnRESULTSnu2002 Female Sexual Function Index indicated that obstructive sleep apnea patients were at a higher risk for having sexual difficulties. Female Sexual Distress Scale showed significantly more sexual distress in the obstructive sleep apnea group. Manifest Female Sexual Dysfunction (combined data from Female Sexual Function Index and Female Sexual Distress Scale) showed that female patients with obstructive sleep apnea also had more sexual dysfunction. Severity of sleep apnea was, however, not related to any of these indices but consumption of psychopharmaca was. In Lisat-11, we found that obstructive sleep apnea females scored lower than women in the population sample regarding life as a whole but not regarding domains of closeness.nnnCONCLUSIONSnu2002 This study indicates that sexuality of women with untreated obstructive sleep apnea is negatively affected compared with a female population sample. This was not related to severity of obstructive sleep apnea, whereas psychopharmaca may act as an important confounder.

Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

Introduction Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. Methods and analysis The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5u2005years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5u2005mmol/L, glycated haemoglobin <48u2005mmol/mol, blood pressure <140/90u2005mmu2005 Hg for patients without diabetes and <130/80u2005mmu2005Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30u2005mg/g) after 1u2005year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1u2005year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60u2005months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60u2005months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia and (4) microalbuminuria (intervention group). Ethics and dissemination This protocol is approved by the local ethics committee (DK-S-2014007) and The Danish Health and Medicines Authority. Dissemination will occur through presentations at National and International conferences and publications in international peer-reviewed journals. Trial registration number NCT02246257

The CopenHeartSF trial - Comprehensive sexual rehabilitation programme for male patients with implantable cardioverter defibrillator or ischaemic heart disease and impaired sexual function : Protocol of a randomised clinical trial

Introduction Sexuality is an important part of people’s physical and mental health. Patients with heart disease often suffer from sexual dysfunction. Sexual dysfunction has a negative impact on quality of life and well-being in persons with heart disease, and sexual dysfunction is associated with anxiety and depression. Treatment and care possibilities seem to be lacking. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation possess the potential of reducing sexual dysfunction in patients with heart disease. The CopenHeartSF trial will investigate the effect of a comprehensive sexual rehabilitation programme versus usual care. Methods and analysis CopenHeartSF is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 central randomisation to sexual rehabilitation plus usual care versus usual care alone. Based on sample size calculations, 154 male patients with impaired sexual function due to implantable cardioverter defibrillator or ischaemic heart disease will be included from two university hospitals in Denmark. All patients receive usual care and patients allocated to the experimental intervention group follow a 12-week sexual rehabilitation programme consisting of an individualised exercise programme and psychoeducative consultation with a specially trained nurse. The primary outcome is sexual function measured by the International Index of Erectile Function. The secondary outcome measure is psychosocial adjustment to illness by the Psychosocial Adjustment to Illness Scale, sexual domain. A number of explorative analyses will also be conducted. Ethics and dissemination CopenHeartSF is approved by the regional ethics committee (no H-4-2012-168) and the Danish Data Protection Agency (no 2007-58-0015) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Registration Clinicaltrials.gov identifier: NCT01796353.