Sleep-related eating disorder (SRED), according to ICSD-3
Conditions
Interventions
Group 1: Administration of Weight-loss drug Wegovy® (Semaglutide): according to Swiss approval for weight loss. Running-in of dosage (timing in-between dosages around 1 month) from 0.25 mg to 0.5 mg,
Sponsors
Klinik Barmelweid, Schlafmedizin & Epileptologie
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • SRED according to ICSD-3 criteria • Fulfilment of treatment indication of Wegovy®: o Willingness for life-style change, as Wegovy® is just adjunct o BMI of: = 30 kg/ m2 (Adipositas) or = 27 kg/ m2 to < 30 kg/ m2 (Overweight) with at least one weight-caused comorbidity, as defined by PI and guided by the Swissmedic information. • Usage of reliable contraception methods, e.g. double contraception, as covered in counselling at visit 0. • Willingness to stop semaglutide treatment at least 2 months before planned pregnancy • Legal age (=18 years) • Informed consent for the study in general, including willingness to participate under this strict schedule. • Informed consent for the home-video, including consent by people declared by participants, who could be captured on home-video in the agreed-upon capturing timeframe.
Exclusion criteria
Exclusion criteria: • Patient not showing any SRED-like behavior during at-home baseline • Treatment with other GLP-1-Agonists • Elective surgeries planned during study time, especially bariatric surgery • Anamnestic renal impairment or development of renal impairment during study • Anamnestic hepatic dysfunction or development of hepatic dysfunction during study • Anamnestic acute gastrointestinal disease or development of gastrointestinal disease during study • Anamnestic pancreatitis or development of pancreatitis during study • Diabetes Mellitus • Anamnestic tendency to hypoglycaemia • Anamnestic diabetic retinopathy or development of diabetic retinopathy during study • Anamnestic diabetic gastroparesis • Anamnestic congestive heart failure New York Heart Association class IV • Age 75 or higher • Anamnestic inflammatory bowel disease or development of inflammatory bowel disease during study • Pregnancy or planning of pregnancy during the study period • Breast-feeding • Anamnestic intolerance against one of the ingredients of Wegovy® (Semaglutide): o “Wegovy FixDose [enthält] Dinatrii phosphas dihydricus, Natrii chloridum, Acidum hydrochloridum/Natrii hydroxidum (q.s. ad pH), Aqua ad iniectabile. Das Arzneimittel enthält 0.078557 mmol Natrium pro Dosisstärke (0.25 mg, 0.5 mg, 1.0 mg) bzw. 0.11785 mmol Natrium pro Dosisstärke (1.7 mg, 2.4 mg).” o «Wegovy Multi FixDose [enthält] Dinatrii phosphas dihydricus, Propylenglycolum, Phenolum, Acidum hydrochloridum/Natrii hydroxidum (q.s. pH), Aqua ad iniectabile q.s. ad solutionem pro 0.37 mL bzw. 0.75 mL. Das Arzneimittel enthält 0,00591 mmol (0.136 mg) Natrium pro Dosisstärke (0.25 mg, 0.5 mg) bzw. 0,01197 mmol (0.275 mg) Natrium pro Dosisstärke (1 mg, 1.7 mg, 2.4 mg).» • Anamnestic Medullary Thyroid Cancer or multiple endocrine neoplasia-syndrome type 2 (MEN 2) or development of Anamnestic Medullary Thyroid Cancer or multiple endocrine neoplasia-syndrome type 2 (MEN 2) • SRED clinically seems to be untypical, caused by different disorder • Other possible factors which might interfere with participant’s safety, adherence or something else, as decided by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of number of sleep-related eating episodes between baseline and stable treatment phase. Clinically relevant reduction is defined as a reduction of documented ingestion episodes of food/ other substances on home video by 50%. Measurement: Combination of data from video-surveillance of kitchen at patient's home, actigraphy and questionnaire (measurement blocks of 14 days before and during treatment). Measurements take place before the first administration of the drug and during (3-4 weeks after the first administration of the highest dosage). Measurement block before treatment starts 28 to 35 days before the first dosage. Measurement block under treatment starts according to standard-intervals 19 weeks after the first dosage of Semaglutide. | — |
Secondary
| Measure | Time frame |
|---|---|
| - feasibility of chosen methods/procedures: In addition to the discussion of feasibility for larger studies with these methods after the completion of this project, we define feasibility a priori as follows: General: • Informed consent of 3 or more patients • Complete participation as of attendance to all visits for 2 or more patients • Completion of all measurements (defined as collected, not necessarily valid (started, not necessarily complete measurements)) for 1 or more patients Camera-specific: • Complete validated (as defined by signs of patient before and after sleep) baseline nights for 2 or more patients • Complete validated (as defined by signs of patient before and after sleep) baseline and second-measurement nights for 1 or more patient • Capture of at least 3 real SRED episode as by our definition • Rate of video-second opinion discussions for measurement less than 50% as total of all eating videos per patient - Most important other measurements: • Actigraphy measurements • Anthropometric data, e.g. changes in BMI, weight, pulse, etc. • Patient diary, e.g. on sleep-quality • Home Video • Electrophysiology: 2x Video-Polysomnography, e.g. sleep-staging (in sleep-laboratory, during the night before the start of measurements at home) • Questionnaires o Questionnaires at baseline for patient characterization: D-MEQ (Morningness-Eveningness Questionnaire), EDI-2 (Eating Disorder Inventory), SSS-V (Sensation Seeking Scale), SPSRQ (Sensitivity to Punishment Sensitivity to Reward), BFI-2 (Big Five Inventory). o Questionnaires at baseline and treatment measurement blocks -> comparison between patients: own-developed questionnaire/ diary (for at home measurement), FSS (Fatigue Severity Scale), ESS (Epworth Sleepiness Scale), PSQI (Pittsburg Sleep Quality Index), NEQ (Night Eating Questionnaire), SEES (Salzburg Emotional Eating Scale), BAI (Beck's Anxiety Index) & BDI (Beck's Depression Index). • Exploratory: o Further descriptive cha | — |
Countries
Switzerland
Contacts
Public ContactNico Julian Zobrist
Klinik Barmelweid, Schlafmedizin & Epileptologie
Outcome results
None listed